Position Summary

We are currently seeking a dedicated and experienced Registered Nurse to support the clinical operations at our La Jolla Clinic. This role is ideal for someone who thrives in a dynamic, patient-centered environment and is passionate about delivering high-quality care while supporting a collaborative clinical team. We are particularly interested in RNs with backgrounds in ICU, hospital, or other acute care settings, as these experiences bring valuable clinical insight and readiness to lead in a fast-paced outpatient environment. 

This is a full-time, non-exempt (hourly) position, scheduled for 40 hours per week. Work hours may vary based on assigned clinic location, Monday through Friday. This role will be based primarily in our La Jolla clinic but may also provide support to other nearby locations. The ideal candidate is adaptable and enjoys collaborating across multiple sites to ensure seamless operations and excellent patient experiences.

Key Responsibilities

• Clinical Procedures & Diagnostic Testing:
  
  • Perform a variety of allergy and asthma testing procedures, including: 
  • Allergy skin testing 
  • Spirometry, DLCO, and fractional exhaled nitric oxide (FeNO) 
  • Mannitol challenges 
  • Drug challenges 
  • Food challenges 
  • Emergency Response & Treatment Administration 
  • Assist in the treatment of anaphylaxis, including: 
    • Administration of injectable epinephrine 
    • IV fluids (ensuring this skillset is proficient)  
    • Oxygen and nebulized medications 
    • Administer intravenous medications and infusions, (In accordance with the California Board of Registered Nursing scope-of-practice guidelines) including: 
    • IVIG 
    • Monoclonal antibody therapies 
• Clinical Oversight & SOP Implementation:
  
  • Oversee the implementation of standard operating procedures (SOPs) across all areas of clinical care, including: 
  • Allergy immunotherapy (injections) 
  • Skin testing protocols 
  • Food and drug challenge protocols 
  • Oral immunotherapy (OIT) treatments 
  • Maintain and manage staff training logs and ensure protocol compliance 
• Clinical Research Coordination:
  
  • Participate in and oversee the conduct of clinical trials: 
  • Supervise administration of investigational products by study coordinators 
  • Support and train clinical research staff; address medical questions 
  • Ensure accurate completion of study documentation, including: 
  • Training logs 
  • Delegation of authority forms 
  • Equipment calibration and maintenance logs 
• Oral Immunotherapy (OIT) Program Management:
  • Oversee the preparation of food allergen solutions 
  • Participate in and supervise: 
  • Food up dosing appointments 
  • In-office food challenges 
• Additional duties as assigned.  

Qualifications & Requirements

• Licensure & Certifications:
  • Licensed RN in the state of California. 
  • Current CPR certification (or willingness to obtain). 
  • Current BLS (Basic Life Support) certification. 
• Experience: 
  • Nursing for 1 year (preferred) 
  • Allergy/immunology experience preferred. 
  • Experience with EMR systems; ModMed experience a plus. 
• Skills & Abilities:
  • Comfortable performing complex tasks and applying independent knowledge and judgment. 
  • Skilled in pulmonary function testing, FeNO testing, and peak flow monitoring. 
  • Phlebotomy experience. 
  • Strong patient education skills regarding medications and environmental controls. 
  • Exceptional attention to detail and organizational skills. 
  • Strong verbal and written communication skills. 
  • Ability to multitask, prioritize duties, and work independently in a dynamic clinical environment. 
  • Professional, compassionate demeanor and a commitment to high-quality patient care. 
  • Handling IV fluids administration and related tasks, including preparation, setup, monitoring of infusion, and documentation, while ensuring strict adherence to clinical protocols and safety standards. Candidate must demonstrate proficiency and confidence in this skillset 
  • Strong organizational and communication skills required; able to work in a team environment 
• Physical Requirements:
  • Ability to stand and walk for extended periods (up to 8-hour shifts). 
  • Occasional lifting of objects weighing 5–25 pounds (up to 4 feet in distance). 
  • Occasional bending, stooping, and reaching for clinical tasks.
  • Frequent use of hands and fingers for patient care, typing, and equipment handling.
  •  Normal (or corrected) vision and hearing required. 
  • Ability to move quickly and efficiently in a fast-paced clinical setting. 
  • Ability to move throughout exam rooms, front office, and supply areas.

Compensation

The hourly range for this position is $38.00 - $55.000/hour. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate’s skills, education, and experience.

🚪 Commercial Garage Door Technician – San Diego, CA
Open the door to your next big opportunity with Garage Door Medics!

Do you take pride in solving problems, enjoy working with your hands, and want to be part of a team that values professionalism, safety, and growth? Join Garage Door Medics, a trusted name in the garage door industry, as we expand our commercial technician team in San Diego!

🛠️ What You'll Do:

As a Commercial Garage Door Technician, you’ll be the face of our company—servicing, installing, and maintaining a variety of commercial and industrial door systems including sectional doors, rolling steel doors, fire doors, dock equipment, and more. You’ll work hands-on, troubleshoot on the spot, and leave customers confident in the safety and performance of their systems.

🔧 Key Responsibilities:

• Install, service, and repair commercial door systems and equipment.

• Perform job site inspections to ensure all work meets safety standards and company expectations.

• Maintain detailed job documentation (notes, diagrams, photos).

• Identify customer needs, recommend solutions, and upsell products when appropriate.

• Prioritize safety at all times and comply with OSHA guidelines.

• Communicate clearly and professionally with customers, team members, and office staff.

• Utilize tools and software (like ServiceTitan) to track jobs and update progress.

✔️ What We’re Looking For:

• Valid driver’s license with a clean driving record.

• Minimum 3 years previous experience in commercial garage door work.

• Able to lift 75+ lbs, climb ladders, and work on your feet.

• Familiar with safety standards and OSHA best practices.

• Tech-savvy and comfortable using mobile apps and documentation tools.

• Strong communication skills and commitment to delivering excellent customer service.

• High school diploma or equivalent required.

🎁 What’s In It for You:

• Competitive pay with room for advancement

• Health, dental, and vision insurance

• 401(k) with company match

• Paid time off + holidays

• Employee discounts and referral bonuses

• Training and certifications to help you grow in your trade

• A tight-knit, family-owned company culture backed by a national network of service professionals

💼 About Garage Pros:
Garage Door medica is a family-owned and operated leader in the garage door industry. We specialize in residential, commercial, and industrial garage door services across the San Diego area. Our mission? Deliver quality craftsmanship, honest service, and unmatched value to every customer, every time.

Ready to build your career with a company that opens doors—literally and figuratively?
Apply today and join a team where your skills, work ethic, and positive attitude will be recognized and rewarded.

Guild Garage Group LLC is an Equal Opportunity Employer AA/EOE/M/F/V/D. In compliance with the Americans with Disabilities Act, Garage Door Medics may provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

All candidates are required to undergo pre-employment Background and Drug Screenings, as well as a Motor Vehicle Record Check.

*This posting provides details on potential commissioned compensation ranges and possibilities. These amounts are not guaranteed and should in no way be construed as a salary offer.

#GuildSP

🚪 Ready to Open the Door to a Six-Figure Career? Join Garage Door Medics in San Diego! 🚪

Location: San Diego, CA
Estimated Annual Pay: $80,000–$120,000+ (Commission after training period — uncapped earnings!)

Are you a motivated, relationship-driven sales professional looking for a role where your hustle truly pays off?

If you love helping homeowners, excel at uncovering needs, and are ready for a role where top performers routinely earn six figures, this is the opportunity you’ve been waiting for.

🔧 What You’ll Do

As a Garage Door Outside Sales employee, you’ll be the trusted expert homeowners rely on for guidance. Your day-to-day will include:

• Meeting homeowners to assess needs and present tailored garage door solutions

• Managing the full sales cycle from first interaction to final follow-up

• Generating and pursuing new leads through calls, emails, and in-home consultations

• Providing accurate, competitive estimates for installs, upgrades, and replacements

• Recommending accessories and enhancements that improve safety, function, and style

• Serving as the primary point of contact throughout each project

• Partnering closely with installation teams to ensure a seamless customer experience

• Maintaining detailed customer information using ServiceTitan

• Participating in ongoing product, safety, and sales training

✅ What We’re Looking For

You’ll thrive in this role if you have:

• 3+ years of proven sales success—preferably in home services, trades, or residential projects

• A strong customer-first mentality and passion for relationship building

• Project management experience (a major plus)

• ServiceTitan or similar CRM experience (or willingness to learn)

• Availability to work evenings, weekends, or holidays as needed

• Ability to lift 50+ lbs and work indoors/outdoors in various weather conditions

• A valid driver’s license and clean driving record

• Strong communication, negotiation, and presentation skills

• Tech-savvy skills with Microsoft Office (Word, Excel, Outlook)

💼 What We Offer

At Garage Door Medics, we invest in our people because your success is our success. Here’s what you can expect:

• Uncapped Earning Potential – Top performers routinely exceed six figures

• Comprehensive Benefits – Medical, Dental, Vision, PTO, Paid Holidays, and 401(k) with match

• Company Vehicle + Gas Card – For all work-related travel

• Employee Discounts and a generous Referral Program

• Supportive, High-Performance Culture – We celebrate wins and help you grow

• Career Growth Path – Training, mentorship, and advancement opportunities

🌟 Your Next Chapter Starts Here

This is more than a sales job—it’s a chance to join an industry-leading team, take control of your earnings, and build a long-term career with a respected, fast-growing company.

If you’re driven, customer-focused, and ready to grow professionally and financially, we want to meet you.

👉 Apply Today and Become the Next Success Story at Garage Door Medics – San Diego!

Guild Garage Group LLC is an Equal Opportunity Employer AA/EOE/M/F/V/D. In compliance with the Americans with Disabilities Act, Garage Door Medics may provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

All candidates are required to undergo pre-employment Background and Drug Screenings, as well as a Motor Vehicle Record Check.

*This posting provides details on potential commissioned compensation ranges and possibilities. These amounts are not guaranteed and should in no way be construed as a salary offer.

🚪 Ready to Open the Door to a Six-Figure Career? Join Garage Door Medics in San Diego! 🚪

Location: San Diego, CA
Estimated Annual Pay: $80,000–$120,000+ (Commission after training period — uncapped earnings!)

Are you a motivated, relationship-driven sales professional looking for a role where your hustle truly pays off?

If you love helping homeowners, excel at uncovering needs, and are ready for a role where top performers routinely earn six figures, this is the opportunity you’ve been waiting for.

🔧 What You’ll Do

As a Garage Door Outside Sales employee, you’ll be the trusted expert homeowners rely on for guidance. Your day-to-day will include:

• Meeting homeowners to assess needs and present tailored garage door solutions

• Managing the full sales cycle from first interaction to final follow-up

• Generating and pursuing new leads through calls, emails, and in-home consultations

• Providing accurate, competitive estimates for installs, upgrades, and replacements

• Recommending accessories and enhancements that improve safety, function, and style

• Serving as the primary point of contact throughout each project

• Partnering closely with installation teams to ensure a seamless customer experience

• Maintaining detailed customer information using ServiceTitan

• Participating in ongoing product, safety, and sales training

✅ What We’re Looking For

You’ll thrive in this role if you have:

• 3+ years of proven sales success—preferably in home services, trades, or residential projects

• A strong customer-first mentality and passion for relationship building

• Project management experience (a major plus)

• ServiceTitan or similar CRM experience (or willingness to learn)

• Availability to work evenings, weekends, or holidays as needed

• Ability to lift 50+ lbs and work indoors/outdoors in various weather conditions

• A valid driver’s license and clean driving record

• Strong communication, negotiation, and presentation skills

• Tech-savvy skills with Microsoft Office (Word, Excel, Outlook)

💼 What We Offer

At Garage Door Medics, we invest in our people because your success is our success. Here’s what you can expect:

• Uncapped Earning Potential – Top performers routinely exceed six figures

• Comprehensive Benefits – Medical, Dental, Vision, PTO, Paid Holidays, and 401(k) with match

• Company Vehicle + Gas Card – For all work-related travel

• Employee Discounts and a generous Referral Program

• Supportive, High-Performance Culture – We celebrate wins and help you grow

• Career Growth Path – Training, mentorship, and advancement opportunities

🌟 Your Next Chapter Starts Here

This is more than a sales job—it’s a chance to join an industry-leading team, take control of your earnings, and build a long-term career with a respected, fast-growing company.

If you’re driven, customer-focused, and ready to grow professionally and financially, we want to meet you.

👉 Apply Today and Become the Next Success Story at Garage Door Medics – San Diego!

Guild Garage Group LLC is an Equal Opportunity Employer AA/EOE/M/F/V/D. In compliance with the Americans with Disabilities Act, Garage Door Medics may provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

All candidates are required to undergo pre-employment Background and Drug Screenings, as well as a Motor Vehicle Record Check.

*This posting provides details on potential commissioned compensation ranges and possibilities. These amounts are not guaranteed and should in no way be construed as a salary offer.

Do you love to work with people, enjoy problem solving, passionate and thrive working in an environment where you can support your community and neighbors?

Opening doors to your dream career!

We’re seeking a positive, personable garage door technicians and installers for a rewarding career opportunity! You’ll connect with new people, tackle tough problems, and raise the bar on an excellent customer experience. We welcome applicants who are interested in upward mobility, a positive work environment, and can’t wait to get started!

At Garage Door Medics, we strive to give our customers the best experience when performing garage door installations, garage door maintenance, and replacing garage door openers. We serve the surrounding metro area with residential, commercial, and industrial garage door services.

We’ll give you the training and tools to perform in a fast-paced, multitasking environment. If you’re a star at your job you will have respect, admiration, excellent compensation, and an opportunity to grow. 

The position is based out of our San Diego, CA office.

Compensation: Hourly + Piece Rate

Responsibilities:

Continuous evolution of skills to amplify both personal acumen and the collective expertise as a team.

Adherence to safety protocols and guidelines. Prioritize personal well-being and foster a secure environment for the team, clients, and broader community.

Uphold accurate records of all work undertaken. Documenting notes, diagrams, and photos. Streamline future maintenance and repairs, elevating operational efficiency.

Thorough inspections of installations and repair, aligning them with industry benchmarks and company standards.

Workmanship guarantees installations and repairs meet the highest safety standards and exceed client expectations.

Maintain a positive, empathetic and professional attitude toward customers and employees at all times

Identify customers’ needs, clarify information, research every issue and provide solutions and/or alternatives

Maintain records of customer interaction, transactions, comments, complaints

Seize opportunities to upsell products when they arise

Understanding our products/services inside and out

Communicate and coordinate with colleagues as necessary

Perform other duties as assigned

Skills/Qualifications:

Valid license and clean MVR

Mechanical aptitude

Saturday availability a must

Experience in garage door installation, repair and maintenance of Commercial door systems a plus (sectional, rolling steel, fire doors, high speed doors, and dock equipment)

Ability to lift 75 plus pounds, climb a ladder and use basic hand tools

Familiar with OSHA safety rules and best practices

Excellent customer service, and organizational skills

Ability to understand root causes of technical situations

Strong verbal communication skills along with active listening

Experience with Service Titan a plus

Ability to use tablets for paperwork

Customer focus and adaptability to different personality types

Ability to multi-task, set priorities and manage time effectively

High school degree

What we have to offer you!

Benefits – Health, Vision, Dental, PTO, Holidays, 401k and matching

Company Vehicle

Employee Discount

Employee Referral

Our focus on growth will create many opportunities to take on more responsibilities and develop into senior roles

Guild Garage Group LLC is an Equal Opportunity Employer AA/EOE/M/F/V/D. In compliance with the Americans with Disabilities Act, Garage Door Medics may provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

All candidates are required to undergo pre-employment Background and Drug Screenings, as well as a Motor Vehicle Record Check.

#GuildSP

🚪 Commercial Garage Door Technician – San Diego, CA
Open the door to your next big opportunity with Garage Door Medics!

Do you take pride in solving problems, enjoy working with your hands, and want to be part of a team that values professionalism, safety, and growth? Join Garage Door Medics, a trusted name in the garage door industry, as we expand our commercial technician team in San Diego!

🛠️ What You'll Do:

As a Commercial Garage Door Technician, you’ll be the face of our company—servicing, installing, and maintaining a variety of commercial and industrial door systems including sectional doors, rolling steel doors, fire doors, dock equipment, and more. You’ll work hands-on, troubleshoot on the spot, and leave customers confident in the safety and performance of their systems.

🔧 Key Responsibilities:

• Install, service, and repair commercial door systems and equipment.

• Perform job site inspections to ensure all work meets safety standards and company expectations.

• Maintain detailed job documentation (notes, diagrams, photos).

• Identify customer needs, recommend solutions, and upsell products when appropriate.

• Prioritize safety at all times and comply with OSHA guidelines.

• Communicate clearly and professionally with customers, team members, and office staff.

• Utilize tools and software (like ServiceTitan) to track jobs and update progress.

✔️ What We’re Looking For:

• Valid driver’s license with a clean driving record.

• Minimum 3 years previous experience in commercial garage door work.

• Able to lift 75+ lbs, climb ladders, and work on your feet.

• Familiar with safety standards and OSHA best practices.

• Tech-savvy and comfortable using mobile apps and documentation tools.

• Strong communication skills and commitment to delivering excellent customer service.

• High school diploma or equivalent required.

🎁 What’s In It for You:

• Competitive pay with room for advancement

• Health, dental, and vision insurance

• 401(k) with company match

• Paid time off + holidays

• Employee discounts and referral bonuses

• Training and certifications to help you grow in your trade

• A tight-knit, family-owned company culture backed by a national network of service professionals

💼 About Garage Pros:
Garage Door medica is a family-owned and operated leader in the garage door industry. We specialize in residential, commercial, and industrial garage door services across the San Diego area. Our mission? Deliver quality craftsmanship, honest service, and unmatched value to every customer, every time.

Ready to build your career with a company that opens doors—literally and figuratively?
Apply today and join a team where your skills, work ethic, and positive attitude will be recognized and rewarded.

Guild Garage Group LLC is an Equal Opportunity Employer AA/EOE/M/F/V/D. In compliance with the Americans with Disabilities Act, Garage Door Medics may provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

All candidates are required to undergo pre-employment Background and Drug Screenings, as well as a Motor Vehicle Record Check.

*This posting provides details on potential commissioned compensation ranges and possibilities. These amounts are not guaranteed and should in no way be construed as a salary offer.

Do you love to work with people, enjoy problem solving, passionate and thrive working in an environment where you can support your community and neighbors?

Opening doors to your dream career!

We’re seeking a positive, personable garage door technicians and installers for a rewarding career opportunity! You’ll connect with new people, tackle tough problems, and raise the bar on an excellent customer experience. We welcome applicants who are interested in upward mobility, a positive work environment, and can’t wait to get started!

At Garage Door Medics, we strive to give our customers the best experience when performing garage door installations, garage door maintenance, and replacing garage door openers. We serve the surrounding metro area with residential, commercial, and industrial garage door services.

We’ll give you the training and tools to perform in a fast-paced, multitasking environment. If you’re a star at your job you will have respect, admiration, excellent compensation, and an opportunity to grow. 

The position is based out of our San Diego, CA office.

Compensation: Hourly + Piece Rate

Responsibilities:

Continuous evolution of skills to amplify both personal acumen and the collective expertise as a team.

Adherence to safety protocols and guidelines. Prioritize personal well-being and foster a secure environment for the team, clients, and broader community.

Uphold accurate records of all work undertaken. Documenting notes, diagrams, and photos. Streamline future maintenance and repairs, elevating operational efficiency.

Thorough inspections of installations and repair, aligning them with industry benchmarks and company standards.

Workmanship guarantees installations and repairs meet the highest safety standards and exceed client expectations.

Maintain a positive, empathetic and professional attitude toward customers and employees at all times

Identify customers’ needs, clarify information, research every issue and provide solutions and/or alternatives

Maintain records of customer interaction, transactions, comments, complaints

Seize opportunities to upsell products when they arise

Understanding our products/services inside and out

Communicate and coordinate with colleagues as necessary

Perform other duties as assigned

Skills/Qualifications:

Valid license and clean MVR

Mechanical aptitude

Saturday availability a must

Experience in garage door installation, repair and maintenance of Commercial door systems a plus (sectional, rolling steel, fire doors, high speed doors, and dock equipment)

Ability to lift 75 plus pounds, climb a ladder and use basic hand tools

Familiar with OSHA safety rules and best practices

Excellent customer service, and organizational skills

Ability to understand root causes of technical situations

Strong verbal communication skills along with active listening

Experience with Service Titan a plus

Ability to use tablets for paperwork

Customer focus and adaptability to different personality types

Ability to multi-task, set priorities and manage time effectively

High school degree

What we have to offer you!

Benefits – Health, Vision, Dental, PTO, Holidays, 401k and matching

Company Vehicle

Employee Discount

Employee Referral

Our focus on growth will create many opportunities to take on more responsibilities and develop into senior roles

Guild Garage Group LLC is an Equal Opportunity Employer AA/EOE/M/F/V/D. In compliance with the Americans with Disabilities Act, Garage Door Medics may provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.

All candidates are required to undergo pre-employment Background and Drug Screenings, as well as a Motor Vehicle Record Check.

POSITION OVERVIEW
Syner-G is seeking a Facilities Technician III with 5–10 years of experience to support the operation, maintenance, and repair of GMP and non-GMP facility systems, utilities, and equipment. This role is responsible for performing advanced maintenance activities, troubleshooting complex issues across multiple building systems, and supporting reliability and compliance requirements in laboratory, manufacturing, and utility environments. The Facilities Technician III works with minimal supervision, handles complex technical challenges, and may guide junior staff as needed to ensure safe and efficient facility operations.

WORK LOCATION
Travel to client sites may be required depending on project demands and client expectations.

KEY RESPONSIBILITIES
(This list is not exhaustive and may be modified as needed.)

• Perform advanced preventive and corrective maintenance activities on mechanical, electrical, HVAC, utility, safety, and building systems across GMP and non-GMP areas.
• Receive, prioritize, and execute work order requests from employees, tenants, and internal customers, ensuring timely and efficient response to facility needs.
• Troubleshoot and resolve complex technical issues involving HVAC systems, electrical distribution, plumbing, mechanical utilities, generators, environmental controls, and related infrastructure.
• Inspect facility systems and equipment to identify maintenance needs, operational risks, or abnormal conditions and escalate issues when required.
• Make repairs directly when possible and coordinate specialized contractors or vendors when complex repairs are needed.
• Work independently with minimal supervision while handling complex maintenance tasks requiring strong technical judgment.
• Maintain accurate maintenance records, including work orders, equipment logs, inventory tracking, and compliance-related documentation.
• Support calibration activities and equipment reliability programs as needed.
• Ensure compliance with all safety regulations, facility procedures, and applicable GMP or regulatory standards.
• Provide technical support, guidance, or mentoring to junior technicians as required.
• Collaborate with cross-functional partners including Laboratory Operations, Engineering, Quality, Safety, and other stakeholders to support continuous facility operations.
• Identify and recommend improvements, upgrades, or cost-effective solutions that enhance system reliability, energy efficiency, or facility performance.
• Perform additional duties as assigned.

QUALIFICATIONS AND REQUIREMENTS

Education

• High school diploma required; technical trade school certifications or equivalent field experience considered.
• Registered apprenticeship, trade license (electrical, plumbing, HVAC, pipefitting, wastewater, steam engineering, marine engineering), or equivalent technical training strongly preferred.

Experience

• 5–10 years of relevant experience in facility maintenance, utilities support, or mechanical/electrical building systems.
• Experience in regulated environments such as cGMP biotech, pharmaceutical, or laboratory operations preferred.

Knowledge, Skills, and Abilities

• Strong technical skills in HVAC, electrical, plumbing, mechanical systems, and building utilities.
• Ability to troubleshoot and resolve complex facilities issues independently.
• Proficient in reading schematics, blueprints, technical manuals, loop diagrams, and P\&IDs.
• Familiarity with Building Management Systems and Computerized Maintenance Management Systems (CMMS).
• Effective communication and customer service skills.
• Ability to perform physical labor and work across multiple facility environments.

ESSENTIAL FUNCTIONS: 

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

The expected salary range for this position is $43 to $50 hourly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

Environmental Specialist II

Triumvirate Environmental, one of the largest environmental services firms in North America, is seeking an Environmental Specialist II for our Lab & Onsite Support Services (Lab/OSS) team. As an Environmental Specialist, you will support our clients on-site by managing their hazardous waste programs & projects, utilizing state & federal regulations. 

Triumvirate Environmental provides leading organizations in the higher education, life sciences, healthcare, and advanced manufacturing sectors with diverse services and expertise to assist them with compliance management. At Triumvirate Environmental, we strive to WOW both our employees and our customers. Our unique culture fosters growth, development, education, and creativity.   

This position reports to the Operations Manager. This role is based on site at client locations in the San Diego area. 

We invite you to watch this video to discover more about the exciting responsibilities of an Environmental Specialist at Triumvirate Environmental. CLICK HERE 

Responsibilities: 

• Develop an understanding of OSHA regulations as well as Triumvirate’s Health and Safety practices 
• Preparation of chemical and biological waste for shipment and disposal, including creation of all federal/state waste documents and managing the paperwork for the material. 
• Safe handling of hazardous waste containers on client sites, as well as loading/unloading of waste from vehicles 
• Conduct safety equipment and hazardous waste inspections. 
• Occasionally perform and document Environmental Health and Safety (EHS) audits for clients. 
• Deliver Exceptional Customer Service: Champion our commitment to the WOW! by providing outstanding support and innovative solutions to our clients 
• Develop a high-level of state and federal regulatory expertise ensuring our client’s compliance needs are met (e.g RCRA, DOT, and OSHA) 
• Coordinate and communicate effectively with clients, vendors, and regulatory agencies regarding waste management processes
• Conduct spill response measures, including the assessment of the spills and cleanup efforts 
• Rotating on-call responsibilities as part of our Emergency Response team (optional)

Basic Requirements: 

• Bachelor's degree with 1-2 years of experience in the hazardous waste industry or relevant military experience 
• Ability to work as a member of a team as well as individually 
• Must demonstrate strong verbal and written communication abilities to effectively interact with clients, colleagues, and stakeholders, ensuring clear and professional exchanges of information 
• Demonstrated ability to analyze complex issues, develop solutions, and implement strategies to achieve positive outcomes 
• Skilled in building strong, positive relationships with clients and colleagues 
• Ability to work overtime on a regular basis 
• Must be willing to work flexible hours within the work week (Monday through Friday) 
• Ability to complete a 2 year professional advancement program in hazardous waste management 
• The Environmental Specialist frequently handles hazardous chemicals and biological waste and is responsible for putting on and taking off personal protective equipment. This role is considered safety-sensitive 
• Must be able to report to the local office within 1 hour during Emergency Response rotating shifts 
• Valid US driver’s license 
• Must have a reliable form of transportation 
• Must be willing to consent to Motor Vehicle Record screening, criminal background check, pre-employment physical, and drug screen (inclusive of THC) 
• Upon employment, you will be required to participate in a random drug screening program (inclusive of THC) as part of our company’s commitment to maintaining a safe and healthy work environment 
• Must be eligible to work in the United States without future sponsorship 
• Must be able to lift 60 pounds on a regular basis 

Preferred Requirements:  

• Prior successful experience in a customer service role 
• Active HAZWOPER 24 or 40 hour certification 
• Willingness to obtain Commercial Driver’s License (CDL) 

#LI-Onsite 

Besides Health, Dental and Vision Insurance, we contribute to a 401k, offer a generous tuition reimbursement program, TONS of safety training for some positions with opportunities for external trainings and certifications, Mentorship & Career Succession Planning, Relocation Opportunities, Auto/Home insurance discounts, pet assistance discount plans, discounted movie passes & more!   

To learn more about our business, culture, and the exciting work that we are doing in the industry, find us on LinkedIn, Instagram (@triumvirateenvironmental), or our website!  

Triumvirate Environmental is committed to a diverse and inclusive workplace. As an Equal Opportunity Employer (EOE), Triumvirate does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individuals with Disabilities and Protected Veterans are encouraged to apply. 

If you have a disability and need accommodation during the application and hiring process, please contact us at https://www.triumvirate.com/contact or call us at 888-834-9697.  The requirements listed above are representative of the knowledge, skill, and/or ability required. To view our California Privacy Notice and Policy, click here. 

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases, ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. Additionally, collaboration with research scientists and external partners is essential to address technical challenges and advance promising compounds toward clinical readiness.

The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues The role will be critical in ensuring that we select developable drug candidates, reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline.

Primary Responsibilities
 

• Designs and develops pharmaceutical formulations to support early stage clinical trials, providing acceleration options such as on-site compounding and impromptu type of drug products.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, oversee operations at existing suppliers.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• With Translational Sciences teams, plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates.
• Develops phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on-site preparations.
• Conduct physicochemical characterizations of the new drug candidates to support developability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with the CMC team, late-stage formulation team, and formulation development management to establish the development strategy for formulation of the new drug candidates.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND, CTA, IMPD)
• Other responsibilities as assigned.

Education/Experience/Skills

Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.  A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.  Demonstrated success in the field of formulations and dosage form development.   Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability, formulations for early stage clinical studies, and dosage form formulation and package development.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel to domestic and international locations is required.

#LI-HYBRID #NC1 

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director will be responsible for the oversight of Translational Science preclinical safety assessment/toxicology deliverables, with a clear understanding of functional interdependence and critical path activities. The role will contribute to the research and/or development of the products, projects, and programs in support of the pipeline.  Collaborate cross‑functionally to conduct basic research and development, including designing and overseeing preclinical safety and toxicology studies in support of diverse projects and long-term company objectives.  Ensure timely and effective communication of project status and issues to drive alignment and successful completion of team goals and deliverables.

Primary Responsibilities

• Plans experimental safety assessment/toxicology programs to include design, logistics, resource allocation, schedules. Identifies critical support needs, and other necessary details to implement the program(s).

• Provides oversight on scientific management of preclinical safety assessment/toxicology studies supporting early drug development spanning lead optimization through IND and NDA submissions and nonclinical post marketing approval requirements.

• Monitors CROs for quality and compliance in the conduct of preclinical safety assessment/toxicology studies.

• Manages vendors and consultants, encompassing study design, detailed coordination of study execution, overview of quality compliance, and scientific rigor.

• Reviews and contributes to preparation of toxicology reports.

• Maintains oversight of test compound delivery, shipment and supply requirements.

• Works cross functionally on projects including an understanding of when broader discussion is required and the organization ad hoc working groups as needed to move project activities forward.

• Communicates project status and proactively identifies issues to ensure that project team goals and regulatory deliverables are met.

• Provides guidance to team members to objectively assess and resolve preclinical safety assessment/toxicology project issues to improve project effectiveness.

• Other duties as assigned.

Education/Experience/Skills

BS or MS in a relevant discipline or a related field. Targeting 8 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development within the pharmaceutical or biotech industry.  DABT Certification strongly preferred. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Understanding of the drug development process and the principles, concepts, practices, and standards of executing preclinical safety assessment/toxicology strategies.

• Knowledge in the tools and procedures of preclinical safety assessment/toxicology experimentation, including the various experimental designs, statistical tools of data analyses, software applications available for data manipulation and presentation, and instrumentation pertinent to the research and ability to evaluate the advantages and disadvantages of each, in terms of applicability to the research at hand.

• Knowledge of the preclinical study types necessary during drug development, including acute and chronic toxicology, safety pharmacology, developmental and reproductive toxicology, genotoxicity and carcinogenicity.

• Experience working in cross-functional project teams and in a semi-virtual environment including CROs and academic collaborations.

• Study monitoring experience on Good Laboratory Practices (GLP) safety assessment/toxicology studies at CROs.

• Experience in the composition and review of preclinical safety assessment/toxicology reports with respect to accuracy, quality and compliance.

• Knowledge and understanding of GLP, ICH and FDA guidance, and other relevant regulations and guidelines.

• Demonstrated skills and abilities in influencing, facilitation, development, and problem solving. Ability to elicit cooperation from a wide variety of sources and to be influential, encouraging and motivating.

• Excellent communication, presentation, consultative, partnership, and interpersonal skills. Self-motivated and able to work with limited supervision. 

• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.

• Must be able and willing to travel as needed.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#transmed

#LI-Hybrid #LI-SL1

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Drug Safety & Pharmacovigilance is a medical safety expert within the Drug Safety & Pharmacovigilance (PV) function, reporting to the Executive Director of Medical Safety. This role serves as the primary medical safety resource for assigned products across the Acadia portfolio, providing hands-on medical evaluation of safety data, signal detection and assessment, and clinical oversight of pharmacovigilance activities throughout the product lifecycle. The Director contributes product-level medical input to cross-functional safety governance, collaborates with the Executive Director of Medical Safety on complex or escalated safety issues, and supports regulatory submissions and health authority interactions for assigned products. 

Primary Responsibilities

• Serves as the primary medical safety resource for assigned Acadia products, providing product-level clinical safety and pharmacovigilance expertise across all stages of development and post-marketing surveillance
• Performs medical evaluation and interpretation of aggregate safety data for assigned products, including signal detection and evaluation, ad hoc safety assessments, and benefit-risk analyses; escalates complex or novel safety issues appropriately
• Assesses safety signals and trends for assigned products and proactively manages potential safety issues in collaboration with cross-functional stakeholders
• Contributes product-level medical input to the Medical Safety team and other cross-functional safety governance bodies
• Performs medical review of all serious adverse events from Acadia clinical trials for assigned products
• Performs retrospective medical review of adverse events for post-marketed products
• Authors Analysis of Similar Events (AOSE) and individual case narratives and comments for ICSRs for assigned products
• Provides oversight for the safety aspects of clinical studies for assigned products, including development and maintenance of product-specific core safety information
• Reviews and approves safety sections of clinical documents for assigned products, including protocols, DSURs, final study reports, and other documents as required
• Formulates response strategies and authors health authority responses for safety-related queries pertaining to assigned products, in collaboration with the Head of Medical Safety
• Provides medical input into Periodic Benefit Risk Evaluation Reports (PBRERs) for assigned products, including clinical interpretation of safety data
• Provides medical and scientific input into Risk Management Plans (RMPs/dRMPs) and REMS programs for assigned products
• Ensures all PV Medical Safety activities for assigned products are performed in compliance with applicable regulations and Acadia standards
• Maintains current knowledge of global regulatory authority regulations and guidance
• Other responsibilities as assigned

Education/Experience/Skills

• MD (Doctor of Medicine) or equivalent medical degree from an accredited institution, with relevant postgraduate clinical training and experience; candidates who are eligible for U.S. medical board certification are preferred. MPH or pharmacoepidemiology training is a plus. 
• 6 to 7 years of relevant drug safety experience, including expertise in safety signal management (signal detection, evaluation, aggregate data review, ICSRs), preferably in a pharmaceutical or biotech environment.  
• Neurology, psychiatry, rare disease, or CNS-related therapeutic area experience strongly preferred
• Advanced knowledge of FDA, EU, and ICH regulations and guidelines related to pharmacovigilance, including clinical trial safety monitoring, post-marketing surveillance, ICSR processing, aggregate reporting, and health authority reporting requirements
• Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data
• Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
• Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
• Strong analytical and critical decision-making skills; ability to manage competing priorities and meet deadlines with minimal oversight
• Experience with pharmacovigilance safety databases (Argus) and signal detection tools
• Familiarity with pharmacoepidemiology concepts and study design
• Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders
• Proficiency in MS Office Suite (Word, PowerPoint, Excel)
• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment
• Must be willing and able to travel both domestically and internationally

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID 

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

Responsible for the oversight of Translational Medicine preclinical safety assessment/toxicology deliverables, with a clear understanding of functional interdependencies and critical path activities.  The role will contribute to the research and/or development of the products, projects, and programs in support of the pipeline. Conducts and collaborates with others on basic research and development including preclinical safety assessment/toxicology studies supporting various projects relevant to long-term objectives of the company. Conducts and collaborates with others on basic research and development including designing and monitoring preclinical safety assessment/toxicology studies supporting various projects relevant to long-term objectives of the company. Responsible for the communication of project status and issues and develops strategies to ensure project team goals and deliverables are met.

Primary Responsibilities

• Plans experimental safety assessment/toxicology programs to include design, logistics, resource allocation, schedules.  Identifies critical support needs, and other necessary details to implement the program(s).

• Provides oversight on scientific management of preclinical safety assessment/toxicology studies supporting early drug development spanning lead optimization through IND and NDA submissions and nonclinical post marketing approval requirements.

• Monitors CROs for quality and compliance in the conduct of preclinical safety assessment/toxicology studies.

• Manages vendors and consultants to complete Translational Medicine safety assessment/toxicology studies for the various programs.

• Responsible for preparation and review of reports and regulatory documents for IND and NDA submissions. Explore innovative approaches to enhance efficiency of toxicology evaluations.

• Supports business development related nonclinical Tox/ADME assessments and due diligence projects by assessing available study data and regulatory submissions, identifying gaps, defining additional nonclinical study plans and test compound requirements, and developing overall project timelines and associated budgets.

• Supports Impurity/Degradant safety assessment reviews requested by Chemistry, Manufacturing, and Controls (CMC) groups, involving public domain literature reviews, evaluating structure activity relationships using in silico databases, and competitive intelligence sources.

• Works across functional areas on projects including lleading and participation in team and sub-team meetings and organizing ad hoc working groups as needed to move project activities forward. 

• Communicates project status and issues and ensures project team goals and regulatory deliverables are met. Clearly presents data, interpretation and recommendations to R&D leadership.

• Provides guidance to team members to objectively assess and resolve preclinical safety assessment/toxicology project issues to improve project effectiveness.

• Other duties as assigned.

Education/Experience/Skills

PhD or DVM in a relevant discipline or related field.  Targeting 10 years of relevant experience in pre-clinical safety assessment/toxicology supporting drug development experience within the pharmaceutical or biotech industry.  DABT Certification strongly preferred.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Advanced understanding of the drug development process and the principles, concepts, practices, and standards of executing preclinical safety assessment/toxicology strategies.

• Broad knowledge in the tools and procedures of preclinical safety assessment/toxicology experimentation, including the various experimental designs, statistical tools of data analyses, software applications available for data manipulation and presentation, and instrumentation pertinent to the research. Through a complete understanding of the tools and design methods, able to evaluate the advantages and disadvantages of each, in terms of applicability to the research at hand.

• In depth knowledge of the preclinical study types necessary during drug development, including acute and chronic toxicology, safety pharmacology, developmental and reproductive toxicology, genotoxicity and carcinogenicity.

• Experience managing cross-functional project teams and working in a semi-virtual environment including CROs and academic collaborations.

• Specific direct study monitoring experience on Good Laboratory Practices (GLP) safety assessment/toxicology studies at CROs.

• Experience in the composition and review of preclinical safety assessment/toxicology reports with respect to accuracy, quality and compliance.

• Knowledge and understanding of GLP, ICH and FDA guidance, and other relevant regulations and guidelines.

• Demonstrated skills and abilities in leading teams and sub-teams, coaching, influencing, facilitation, development, and problem solving. Passion for science and teamwork with self-motivation and ability to work with limited supervision.

• Excellent communication, presentation, consultative, partnership, and interpersonal skills. Ability to elicit cooperation from a wide variety of sources and to be persuasive, encouraging and motivating.

• Ability to learn, understand and apply new technologies, strategies and approaches that enhance the team’s ability to achieve goals and meet timelines/deliverables.

• Willing and able to travel as needed.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#transmed

#LI-Hybrid #LI-SL1

THE OPPORTUNITY

Silvus is seeking a Senior Radio Frequency (RF) Design Engineer reporting to the Director of RF Engineering on the RF Engineering team. The successful individual in this role will actively participate in all aspects of the design process to develop the RF subsystem for Silvus’ StreamCaster MANET product line. 

This position is 100% onsite, Monday through Friday, at our office located in Rancho Bernardo, North San Diego CA. 

The following is a list of at least some of the current essential job functions of the position. Management may assign or reassign duties and responsibilities at any time at its discretion. 

ROLE AND RESPONSIBILITIES

• Antenna to baseband RF subsystem design using discrete circuitry or highly integrated RFICs.
• Discrete design includes PLL, LNA, Mixers, PA etc.
• Implementing or supervising schematic capture and PCB layout.
• Radio frequency performance characterization, tuning, and troubleshooting.
• Overall system design to ensure good EMI performance.
• Ensure circuit board design and overall radio product can pass emission and immunity regulations.
• Troubleshoot radio frequency-related production yield problems.
• Improve design for manufacturability.
• Rare local travel, as required by Silvus (i.e. Irvine, West LA).
• Perform other related duties, of which the above are representative.

REQUIRED QUALIFICATIONS

• Bachelors of Science degree in Electrical Engineering.
• Minimum 5 years of multi-GHz RF hardware development experience.
• Good working knowledge of RF board layout, fabrication, and packaging.
• Hands-on experience with solving EMI, harmonics, spurious, and stability issues.
• Experience using RF simulation tools (i.e. AWR Microwave Office, Altium).
• Must be a U.S. Person (permanent resident or citizen) due to U.S. government contracts.
• Employment is contingent upon the successful clearance of a background check and drug test.

PREFERRED KNOWLEDGE, SKILLS, AND ABILITIES

• Master of Science degree in Electrical Engineering.
• Excellent bench skills.
• Proactive approach to problem-solving.
• Detail-oriented and a firm commitment to quality.
• Ability to work in a collaborative, multidisciplinary team environment.
• Problem-solving, data analysis, deductive reasoning, and critical thinking skills.

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS

• Office environment.
• Occasional exposure to heat, cold, and allergens while performing tests or demonstrations in the field.
• While performing the duties of this job, the employee is required to do the following:
  • Lift equipment up to 20 lbs. for the set-up of demonstrations and testing.
  • Perform bending and reaching movements to place items on lower and higher shelves.
  • Kneeling or squatting to access lower shelves.
  • Walking/Moving in the labs

Environmental Technician 

Triumvirate Environmental, one of the largest environmental services firms in North America, is seeking an Environmental Technician for our San Diego, CA office.  

This highly motivated, detail-oriented, customer service-focused individual will be responsible for working on site for the client by helping them manage their hazardous waste programs.

Triumvirate Environmental provides leading organizations in the higher education, life sciences, healthcare, and advanced manufacturing sectors with diverse services and expertise to assist them with compliance management. At Triumvirate Environmental, we strive to WOW both our employees and our customers. Our unique culture fosters growth, development, education, and creativity.   

This position reports to the Operations Manager. This role is onsite at a client and is based in the San Diego area. 

Responsibilities: 

• Technical: 
  • Maintain good attendance and punctuality. 
  • Developing a strong working knowledge of computer software programs that support the operation. 
  • Assist Program Manager as requested. 
• Hands-on: 
  • Handle chemicals and hazardous waste in small and large containers. 
  • Utilization of a material shredder. 
  • Willingness to wear a respirator for 2 to 6 hours per day. 
• Customer Service: 
  • Provide clients with high-quality and professional customer service. 
  • Positive attitude, high energy, and good communication skills. 
  • Rotating on-call responsibilities as part of our Emergency Response team (optional)   

Basic Requirements: 

• High School Diploma or equivalent required. 
• Valid driver's license and clean driving record. 
• Basic knowledge of, or interest in, the hazardous waste field. 
• 1+ years of customer service experience. 
• Self-motivated person with the desire to learn. 
• Must be eligible to work in the United States without future sponsorship 
• Must have a reliable form of transportation 
  
• Must be willing to consent to Motor Vehicle Record screening, criminal background check, pre-employment physical, and drug screen (inclusive of THC) 
  
• Upon employment, you will be required to participate in a random drug screening program (inclusive of THC) as part of our company’s commitment to maintaining a safe and healthy work environment 
  
• Must be able to lift 60 pounds on a regular basis 
  
• Ability to work overtime on when needed
  
• The Environmental Technician frequently handles hazardous chemicals and biological waste and is responsible for putting on and taking off personal protective equipment. This role is considered safety-sensitive. 

Preferred Requirements: 

• Prior relevant industry experience 
• Active HAZWOPER 24 or 40 hour certification
• Forklift Experience 

#LI-Onsite 

Besides Health, Dental and Vision Insurance, we contribute to a 401k, offer a generous tuition reimbursement program, TONS of safety training for some positions with opportunities for external trainings and certifications, Mentorship & Career Succession Planning, Relocation Opportunities, Auto/Home insurance discounts, pet assistance discount plans, discounted movie passes & more!   

To learn more about our business, culture, and the exciting work that we are doing in the industry, find us on LinkedIn, Instagram (@triumvirateenvironmental), or our website!  

Triumvirate Environmental is committed to a diverse and inclusive workplace. As an Equal Opportunity Employer (EOE), Triumvirate does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individuals with Disabilities and Protected Veterans are encouraged to apply. 

If you have a disability and need accommodation during the application and hiring process, please contact us at https://www.triumvirate.com/contact or call us at 888-834-9697.  The requirements listed above are representative of the knowledge, skill, and/or ability required. To view our California Privacy Notice and Policy, click here. 

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

We are actively seeking qualified candidates to join our talent pipeline for future client engagements.  

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

POSITION OVERVIEW:

We are seeking a Facilities Technician with experience in the management, execution, and day-to-day support of building and plant operations, including labs, manufacturing plants, utilities, equipment, and systems. The ideal candidate will perform routine inspections, maintain documented records, and be on-call for emergencies, ensuring compliance with regulatory requirements and GMPs. Effective communication and collaboration with various departments are essential to meet the facility’s needs and quickly resolve any issues. 

WORK LOCATION:

Travel to client sites may be required up to 100%, based on project demands and client expectations.

KEY RESPONSIBILITIES: 

(This list is not exhaustive and may be supplemented and changed as necessary.) 

• Schedule, coordinate, and oversee outside service providers for routine CM and PM Program tasks provided under building, system, or equipment maintenance contracts. 
• Support verification and maintenance with PIDs, HVAC, electrical, one-lines, and process flow diagrams (PFDs). 
• Ensure all Corrective Maintenance and Preventative Maintenance Program tasks are completed and documented properly according to policies and procedures. 
• Perform, schedule, coordinate, and oversee emergency troubleshooting and repair on various HVAC, mechanical, utility systems, and lab and manufacturing equipment (GxP and non-GxP). 
• Perform routine inspections of equipment and facility utilities to identify any issues before they become major problems, looking for signs of wear, leaks, or any abnormalities. 
• Maintain documented records of inspections, preventative maintenance activities, and any repairs following approved SOPs and Work Instructions to ensure compliance, audits, and tracking the overall state of the facility, utilities, and equipment. 
• Respond to alarms and emergencies, such as equipment failures or power outages, with a clear understanding of the facility’s emergency response procedures. 
• Work closely with other departments, such as engineering, manufacturing, quality control, and research and development, ensuring effective communication to meet the facility’s needs. 
• Troubleshoot systems to quickly identify and resolve issues. 
• Prioritize tasks and manage time effectively with minimal oversight. 

QUALIFICATIONS AND REQUIREMENTS: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. 

Education: 

• Bachelor’s degree in a related field. 

Technical Experience: 

• Minimum of 2-6 years of Project/Facilities Engineering experience or experience working as a General Contractor, Construction Manager, or Subcontractor. 
• Facilities background preferred. 
• Process Equipment experience. 
• CAPEX experience. 
• GMP cleanroom experience. 
• Demonstrated understanding of facility systems, utilities, and equipment.  

Knowledge, Skills, and Abilities: 

• Adhere to all procedures, safety protocols, wear appropriate personal protective equipment (PPE), and be aware of emergency procedures. 
• Familiarity with regulatory requirements and good manufacturing practices (GMPs). 
• Must have strong collaboration, communication, prioritization, and problem-solving skills. 
• Highly motivated, independent, detail-oriented team player with good organization, initiative, and a collaborative attitude. 

ESSENTIAL FUNCTIONS: 

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

COMPENSATION:

The expected salary range for this position is $31 to $42 hourly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

ESSENTIAL JOB FUNCTIONS:

• Day-to-day operation and maintenance of laboratory and office facilities.
• Organize and help maintain the lab, manage the lab consumable inventory, take care of stocking supplies, schedule refrigerator/freezer cleanings, pipette calibrations, maintain organization of the lab inventory.
• Order, stock, and track inventory which includes reagents, consumables, first aid items, and other lab and office supplies.
• Arranging FedEx Shipments and receiving deliveries.
• Manage service providers and vendor contracts related to the maintenance, calibration, and repair of facility and utility equipment and building systems.
• Maintain the labs facility and utility practices, policies, and procedures
• Coordinate the instrument preventive maintenance schedule.
• Ensures adherence to lab standards and practices to maximize safety and operational effectiveness
• Responsible for lab shipments to/from company while maintaining safe shipping and handling standards.
• Manage all chemical and biological waste streams, including proper storage, labeling and disposal.
• Maintain required Chemical Inventory.
• Manage system for Safety Data Sheet (SDS) record keeping.
• Track warranty expirations and contact vendors for renewal.
• Drive continuous improvement in all aspects of the laboratory operations
• Provide excellent customer service when interacting with lab users, third party vendors, and other departments
• Proactive communication with end users on scheduled maintenance, status updates, and issues that may impact lab use
• Assist with arranging maintenance and service on equipment
• Escort service vendors for equipment maintenance and repairs
• Serve as EH&S point of contact and safety monitor
• Support and lead city/state inspections and audits
• Monitor systems, liquid nitrogen, and dry ice levels; place orders as needed
• Act as first responder for temperature alarm systems
• Manage and act of PoC for HVAC in office and lab spaces.
• Respond to urgent lab issues such as equipment failures, sample transfers, leaks or facility related issues
• General facilities duties such as lunch orders, stocking kitchen, and running dishwasher
• Provide back-up reception support as needed.
• Assist facilities team with event setup.
• Other tasks as may be assigned as needed

JOB SPECIFICATIONS:

• Prefer a Bachelor’s degree or a combination of equivalent education, training or experience.
• 2+ years of job experience working supporting lab operations in a biotech or pharmaceutical setting
• Ability to speak effectively and communicate to visitors in a professional manner. 
• Ability to work in a flexible, fast-changing environment and respond to needs quickly.
• Must be a team player who excels at customer service. 
• Will be detail oriented with strong attention to detail and have demonstrated experience prioritizing and organizing multiple tasks simultaneously. Punctuality and a positive, cheerful attitude is a must.
• Must be able to stand on your feet for long periods of time and lift 25+lbs

The base range for this role is $21 - $30 per hour. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

MG Properties is seeking a dynamic, customer service oriented and highly organized individual to join our team as a Resident Services Coordinator to work at our property, Luma Apartments, in San Diego, CA.

The Resident Services Coordinator is the property's administrative representative whose primary duty is to provide timely, informative and positive communication that will create a great and optimized resident experience. These responsibilities include resident correspondence surrounding lease questions, service requests and sales when required as well as coordinating resident events. This includes responding to email queries, communication via the que, work orders when needed, and planning monthly events

Essential Responsibilities:

• Conduct all business in accordance with company policies and procedures, Fair Housing, Americans with Disabilities Act, Fair Credit Reporting Act, and all other laws pertaining to apartments.
• Organize, prepare and distribute monthly property newsletter and events calendar, to include outside marketing and advertising.
• Plan and oversee all resident events; quarterly, monthly and weekly.
• Organizes and coordinates staff events.
• Monitor budget and expenses.
• Monitor activities at events to ensure orderly conduct.
• Promotes positive, proactive resident relations, working to enhance the living experience of the resort.
• Assists and performs Leasing Duties as needed.
• Updates internet and magazine advertising as needed to maximize rental growth.
• Remain current in all competitor functions, pricing and marketing programs in place.
• Assists with all aspects of the Leasing Office as needed.
• Oversees activities and enforces policies and rules regarding use of facilities.
• Operates equipment provided in facilities (e.g. exercise equipment).
• Answers phones to schedule use of facilities.
• Abilities to handle emergency situations for incidents that may occur under your supervision and to notify the appropriate authority or emergency service (911 and property manager).
• Accepts and inputs service requests
• Follows all safety procedures and notifies supervisor of safety hazards and any equipment failure.

Qualifications

• Strong verbal and written English communication skills.
• Excellent customer service skills.
• Must have basic working knowledge in computer skills.
• High reasoning ability. Able to apply principles of logical thinking to define problems, collect pertinent data, establish facts, draw valid conclusions and initiate appropriate courses of action.
• Ability to plan, organize, and prioritize work.
• Punctual and reliable.
• Valid Driver’s License and proof of insurance
• Some travel to areas outside property location.

 Compensation and Benefits

• $22-$23/hr DOE
• Monthly and Performance based incentive bonuses
• Company profit sharing
• Accrues 10 days Paid time off per year
• 10 Paid Holidays and 2 Paid Personal Days per year
• 40 Hours of Paid Sick Time
• 401K with employer match
• Medical, Dental, Vision, Employee Assistance Program
• Life Insurance
• Flexible Spending Account, Dependent Care Spending Account
• Rental Discounts

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox™ technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.  

Position Summary

The Manager/Senior Manager of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.

Key Duties and Responsibilities

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.

• Successfully lead global and cross-functional quality projects

• Maintains current knowledge of ever-changing clinical quality guidance and regulations.

• Excellent communication and people skills to ensure cohesive and collaborative teamwork. 

• Demonstrated ability to implement and collaboratively drive company initiatives and policies.

• Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred.

• Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).

• Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions. 

• Establish Quality and Cross-Functional SOPs, processes and associated documents. 

• Working closely with clinical pharmacovigilance team on supporting clinical trial safety. 

• Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management. 

• Other duties as assigned. 

Desired Education, Skills and Experience

• B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
• Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
• Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experience preferred.
• Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
• Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience is a plus.
• Pharmacovigilance/Safety QA experience is a plus.
• Medical Device GCP experience is a plus.
• ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus.
• Medical Device Reporting (MDR) – FDA 21 CFR Part 803.
• Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring.
• Experiences with Clinical Quality Management on a risk-based approach is needed.
• Electronic TMF, document, quality, and learning management systems experience
• Strong organizational and project management skills.
• Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
• Professional working proficiency in English

REQUIREMENTS:

Physical Demands

• None, other than those necessary to perform the essential job functions

Manual Dexterity

• None, other than those necessary to perform the essential job functions

Audible/Visual Demands

• Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment

• None, other than those necessary to perform the essential job functions.

Travel

• Up to 30%

The expected salary range for this position based in California is $150,000 to $170,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

Scientist III – NGS and Cellular Assays, Ingredient Discovery

Location: San Diego, CA (Onsite full-time required)

Summary

As a member of the Ingredient Innovation team, you will design, optimize, and execute high-throughput next-generation sequencing (NGS) assays to support the discovery of novel skincare ingredients. The successful candidate will work collaboratively with the bioinformatics team to design robust, reproducible assays and iterate experimental design based on sequencing outputs. This role will also lead the development and implementation of liquid handling robotics and automation solutions to scale NGS workflows. This is a highly collaborative role that will interact with bioinformatics, assay development, and AI/ML teams to bring novel, scientifically backed ingredients to market.

Essential Functions

• Design, test, and execute high-throughput NGS workflows including human cell culture, RNA extraction, RNA-seq library preparation, quality control, and sequencing on the Illumina platform
• Develop and optimize NGS library prep and cell-based protocols to enhance assay performance
• Collaborate with bioinformatics teams to interpret sequencing outputs, troubleshoot data quality issues, and iterate on experimental design
• Maintain rigorous sample tracking, QC metrics, and documentation to ensure data integrity and reproducibility
• Develop and implement liquid handling robotics and automation platforms for NGS library preparation, sample manipulations, and other high-throughput workflows
• Mentor junior scientists and associates on NGS best practices, cell culture techniques, and robotics operation 

Education and Experience

• PhD with 4 years of experience OR MS with 10 years of experience OR BS with 12 years of wet-lab experience in NGS assay development or relevant field
• At least 5 years of experience in developing, optimizing, running, and troubleshooting challenging NGS assays
• Proficiency with liquid handling robotics and automation scripting
• Proficiency in mammalian cell culture, drug discovery, and/or cell biology techniques (e.g., flow cytometry, fluorescent imaging, luciferase reporter assay, ELISA) is a plus
• Strong organizational skills with experience managing multiple projects simultaneously in a fast-paced environment

Essential Physical Characteristics

The physical characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. 

• Continuous upward and downward flexion of the neck. 
• Frequent: sitting, repetitive use of hands to operate computers, printers and copiers. 
• Frequently uses hands to feel objects or control tools (e.g. pipetting).  Laboratory operations require dexterity and care to perform studies as required.
• Occasional: walking, standing, climbing stairs, bending and twisting of neck, bending and twisting of waist, squatting, simple grasping, reaching above and below shoulder level, and occasional lifting and carrying of files or material weighing up to 50 pounds.
• Must be willing to work with biohazardous agents (up to BSL2) and chemicals.
• The R&D laboratory will result in exposure to hot and cold temperatures, noise, fumes, limited dust, and oily coolants.
• The performance of this position will present exposure to an industrial environment and requires support and compliance with the published Company PPE policy including but not limited to the use of personal protective equipment such as safety glasses with side shields, appropriate attire, safety shoes, hard hat, hearing protection, etc.

Condition of Employment

As part of Debut’s pre-employment process, prospective candidates will undergo a background check prior to beginning employment. Additional types of background investigations may be conducted based on the job-related activities of the position.

Debut is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

Salary: $110,000 - $140,000

Position Summary

The Director/Senior Director of Global Regulatory Affairs (GRA) will report to the Senior Vice President of Regulatory Affairs and serve as a key leader in shaping and executing global regulatory strategies. This role will partner closely with the GRA team and cross-functional stakeholders to ensure compliance with international regulatory requirements and alignment with company objectives. The candidates major responsibilities will include the following:

• Regulatory Strategy & Advice: Develop and execute integrated regulatory strategies that optimize approval pathways for drug and device across all regions where clinical studies are conducted. Provide expert guidance on global regulatory requirements, life cycle management and evolving policies where RM is pursuing development and commercialization.

• Submission Oversight: Lead cross-functional teams to prepare high-quality regulatory submissions. Review and ensure consistency of regulatory documents with company strategy and health authority standards; manage submission strategies for all Rakuten Medical projects from early-stage (IND/CTA) through NDA/BLA and lifecycle management. Oversee planning and execution of global regulatory authority meetings, including briefing packages, strategy, positioning, and negotiations.
• Documentation & Compliance: Ensure compliance with all applicable global laws, regulations, and standards (eg FDA CFR, EMA guidelines, ICH, PMDA standards, EU MDR/IVDR, GCC regulations). Maintain regulatory filing and archiving systems; ensure documentation meets health authority requirements and guidance.
• Project Management: Develop regulatory project plans and timelines; coordinate submission team and regulatory department meetings; track goals, action items, and submission progress. Manage various regulatory vendors and contractors toward budget- and time-efficient completion of corporate goals. Proven ability to apply strong influence skills in leading cross-functional regulatory submission teams.
• Cross-Functional Collaboration: Work closely with teams in CMC, nonclinical, clinical development, medical writing, safety/PV, quality assurance, medical affairs, and program management to support timely and compliant submissions. Assess regulatory risk and drive mitigation strategies to support business continuity.
• Global Tracking: Monitor regulatory commitments, deliverables, and submission content across regions.

This position spans all functional areas requiring regulatory input, including early research, CMC, device, nonclinical, clinical development and commercial. The ideal candidate will bring strong leadership, strategic thinking, and deep knowledge of global regulatory frameworks to drive successful outcomes.

Key Duties and Responsibilities 

• Develop and execute integrated global regulatory strategies for drug and device programs across all regions as required.
• Maintain a thorough understanding of current and emerging global and regional regulations, guidance documents, and ICH standards for all application types and procedures, in all regions where the organization seeks to develop and commercialize products.
• Stay informed on regulatory requirements for biologics and combination products across all regions.
• Develop and manage submission strategies for all Rakuten Medical projects and planned submissions. Ensure regulatory documents are scientifically sound, consistent, and aligned with company strategy and health authority expectations.
• Coordinate and oversee the planning, preparation, and delivery of regulatory submissions throughout the product lifecycle—from preclinical and IND/CTA through clinical development, NDA/BLA, and ongoing lifecycle management.
• Serve as the primary interface with publishing and other regulatory vendors; review submissions for completeness and compliance with regulatory guidance and health authority expectations.
• Lead implementation of new regulatory systems and develop associated processes and SOPs.
• Manage regulatory project tracking tools to monitor deliverables, commitments, submission content, amendment and approval dates, and provide proactive status updates for all regions.
• Act as the primary regulatory lead on assigned project teams, providing strategic input and regulatory support.
• Ensure timely storage and archiving of regulatory documentation in a manner that facilitates efficient retrieval.
• Conduct regulatory review of external-facing materials (e.g., manuscripts, posters) as appropriate.
• Review clinical, CMC, and safety documentation to ensure regulatory compliance and completeness during authoring and finalization.
• Coordinate safety reporting and collaborate with Safety/Pharmacovigilance to ensure systems are in place for efficient tracking and reporting of safety information.
• Assist with onboarding new employees and manage consultants and related contracts as needed.
• Contribute to continuous improvement of operational processes for regulatory submissions and document trackin. 

Qualifications:

• Education:
  • Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline (M.S., Ph.D., or Pharm.D.).

• Experience:

• • 10+ years of regulatory affairs experience in the biopharmaceutical industry, with at least 5 years in a leadership role.
  • Proven track record of managing global regulatory submissions (IND/CTA, NDA/BLA, MAA) and lifecycle management.
  • Experience in oncology or biologics preferred; combination product/device experience is a plus.

• Knowledge:

• • Deep understanding of global regulatory frameworks (FDA, EMA, PMDA, and other major health authorities).
  • Familiarity with ICH guidelines, GCP, and evolving regulatory trends.

• Technical Skills:

• • Expertise in regulatory strategy development and execution.
  • Strong document review and submission planning skills.
  • Proficiency with regulatory information management systems and electronic submission platforms (eCTD).

Key Competencies:

• Strategic Thinking: Ability to anticipate regulatory challenges and develop proactive solutions aligned with business objectives.
• Leadership & Collaboration: Skilled at leading cross-functional teams and influencing stakeholders across global regions.
• Communication: Exceptional written and verbal communication skills for health authority interactions and internal alignment.
• Project Management: Strong organizational skills with the ability to manage multiple priorities and meet tight deadlines.
• Problem-Solving: Analytical mindset to resolve complex regulatory issues and adapt to changing requirements.
• Integrity & Compliance: Commitment to ethical standards and regulatory compliance in all activities.

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

The expected salary range for this position based in California is $150,000 to $190,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

We are looking for an experienced Maintenance Supervisor to oversee all aspects of maintenance and repair at our beautiful community, Shift Apartments, in San Diego, CA!

As a Maintenance Supervisor your duties will include, but are not limited to:

• Diagnosing and performing or delegating minor and routine maintenance
• Overseeing and inspecting work performed by maintenance staff
• Managing system for handling resident service requests
• Assisting manager in coordinating and directing the maintenance staff and scheduling of maintenance personnel
• Conducting regularly scheduled safety meetings
• Maintaining accurate records regarding preventive maintenance requests and expenditures
• Coordinating or performing equipment maintenance and more!

Qualifications

• At least 2 years experience as a Maintenance Supervisor preferred!
• Must have maintenance experience with at least 150 units!
• Must have experience in all trades.
• Must be a team player with a superior customer service attitude. 
• Must have a valid driver's license and reliable transportation. 

Compensation and Benefits

• $42-$45/hour DOE
• Monthly bonuses
• Company profit sharing
• Accrues 10 days Paid time off per year
• 10 Paid Holidays and 2 Paid Personal Days per year
• 40 Hours of Paid Sick Time
• 401K with employer match
• Medical, Dental, Vision, Employee Assistance Program
• Life Insurance
• Flexible Spending Account, Dependent Care Spending Account
• Rental Discounts

GDBA’s Mission: The Safety, Privacy, and Wellbeing of our Clients 

A newly hired Protector in San Diego will earn no less than $81,000 in base earnings during their first year with GDBA. San Diego-based Protectors could earn up to $100,000 in first year earnings when accounting for prior relevant experience, GDBA Training Academy performance, and promotion opportunities. 

To learn more about earnings, promotions, benefits, and more – visit GDBA.com/careers

Your Role as a Protector: 

• Monitor property while utilizing the tools and technology of a GDBA Command Center 
• Screen visitors and vendors; control all access to protected site 
• Coordinate and execute security plans and respond to medical emergencies 
• Provide physical protection and logistical support at clients' homes and when they travel 
• Provide secure transportation as needed 
• Survey and prepare (advance) locations prior to arrival of client 
• Prepare detailed documentation of suspicious activity 
• Create and maintain readiness to meet any threat 

Hiring Process Requirements:

• 12-Day Introductory Essential Protector Skills (EPS) Training Academy in San Antonio, TX
• Be able to pass physical readiness test (Pull-ups, Push-ups, Sit-ups, 800m run)
• Must be able to swim
• Must be drug and nicotine free
• Background check required
• Must be able to obtain appropriate state firearm and security licensing

Treeline Biosciences, a clinical-stage biotechnology company advancing precision medicines, is seeking an experienced small molecule process chemist to drive the development, scale-up, and commercial readiness of our small molecule, clinical-stage portfolio. This role centers around close collaboration with the medicinal chemistry team within the discovery portfolio. Additionally, the role is critical to ensuring clinical supply and commercial readiness for identified programs and ensuring that drug substance manufacturing processes meet quality, regulatory, safety, scalability, and scalability expectations. 

About the Position

Senior Scientist / Principal Scientist – Process Chemistry (Discovery Process Research)

Position Overview

We are seeking an experienced synthetic chemist to join our Process Chemistry (Discovery Process Research) team supporting drug discovery programs. This role focuses on route invention, reaction development, and scalable synthesis of key intermediates and drug candidates.

The scientist will lead from the bench within our project-based research and development organization, designing and executing synthetic strategies that enable discovery programs. The successful candidate will collaborate with cross-functional teams, including Medicinal Chemistry, DMPK, Toxicology, Drug Product, and Analytical Sciences to develop practical routes that support SAR exploration and deliver material for biological and early toxicology studies. The role emphasizes modern synthetic methodologies, efficient route design, and early scalability assessment.

Scientific Impact

• Enable drug discovery through innovative synthetic strategy. Develop creative and efficient routes that accelerate SAR exploration, enable rapid evaluation of new chemical matter, and deliver material for early toxicology studies.
• Solve complex synthetic challenges. Apply modern synthetic methodologies to access structurally complex molecules and support emerging therapeutic modalities.
• Translate discovery chemistry into scalable processes. Design practical routes that support both rapid compound synthesis and early-stage scale-up.
• Advance cross-disciplinary drug discovery. Partner closely with discovery scientists to translate synthetic innovation into therapeutic progress.

Responsibilities

• Collaborate with medicinal chemistry partners to support candidate selection and developability assessments.  Advise and assist with sourcing scaffolds and intermediates as appropriate. 
• Design and execute route scouting and synthetic strategies for drug candidates and key intermediates.
• Design and optimize chemical transformations and scalable synthetic routes to enable efficient and robust processes for discovery and early development programs.
• Enable rapid compound synthesis and methodologies to support SAR campaigns and discovery timelines.
• Apply modern synthetic technologies to address complex synthetic challenges.
• Support multi-gram to kilogram-scale synthesis for biological and toxicology studies.
• Manage external partners and cultivate strong, collaborative relationships to support program objectives.
• Contribute to early CMC understanding, including impurity identification and process considerations.
• Communicate results through technical reports, documentation, and presentations.
• May be involved with preparations for the first GMP synthesis of a clincial candidate for Phase 1 trials.
• Ability to travel up to 10% to support program needs, including on-site support at manufacturing plants and partner collaboration.

Qualifications

• Ph.D. in Organic Chemistry or related discipline with 3–8+ years of relevant industry or postdoctoral experience; M.S. with 6–10+ years of industry experience also considered.
• Strong expertise in synthetic organic chemistry, reaction development, and route design.
• Experience with complex molecule synthesis and route optimization.
• Familiarity with scale-up considerations and impurity control in chemical processes.
• Ability to work effectively within cross-functional discovery teams.
• Experience working with and managing external CDMO partners. 
• Strong written and verbal communication skills.
• Strong project leadership skills with the ability to manage complex timelines, multiple stakeholders, and evolving program priorities. 
• Strong communication and collaboration skills with a proven ability to work cross-functionally in a fast-paced, science-driven environment. 
• High level of personal integrity, commitment to excellence and to our patients 

Desired Experience

• Experience with modern synthetic methodologies and technologies (e.g., catalysis, flow chemistry, photochemistry, high-throughput experimentation, as well as other techniques).
• Experience enabling synthesis of structurally complex drug candidates or emerging modalities.
• Demonstrated creative problem solving in synthetic chemistry.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in San Diego is $166,380 to $189,533. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

Recruitment fraud statement

Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:

• Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
• We do not conduct interviews through RingCentral, Skype or Telegram.
• Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
• You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
• To report job scams, head to ReportFraud.ftc.gov.

THE OPPORTUNITY

Silvus Technologies is seeking an RF Design Engineer who will report to the Director of RF Engineering on the RF Engineering team. The successful individual in this role will actively participate in all aspects of the design process to develop the RF subsystem for Silvus’ StreamCaster MANET product line.  This position is 100% onsite Monday through Friday at our office located in Rancho Bernardo, North San Diego CA. 

The following is a list of at least some of the current essential job functions of the position. Management may assign or reassign duties and responsibilities at any time at its discretion. 

ROLE AND RESPONSIBILITIES

• Antenna to baseband RF subsystem design using discrete circuitry or highly integrated RFICs.
• Discrete design includes PLL, LNA, Mixers, PA etc.
• Implementing or supervising schematic capture and PCB layout.
• RF performance characterization, tuning, and troubleshooting.
• Overall system design to ensure good EMI performance.
• Ensure circuit board design and overall radio product can pass emission and immunity regulations.
• Troubleshoot RF-related production yield problems.
• Improve design for manufacturability.
• Rare local travel to other company locations, as required (i.e. Irvine, West LA).

REQUIRED QUALIFICATIONS

• Bachelors of Science degree (or higher) in Electrical Engineering.
• Minimum 2 years of multi-GHz RF hardware development experience.
• Good working knowledge of RF board layout, fabrication, and packaging.
• Hands-on experience with solving EMI, harmonics, spurious, and stability issues.
• Experience using RF simulation tools (i.e. AWR Microwave Office, Altium).
• Must be a U.S. Person (permanent resident or citizen) due to U.S. government contracts.
• Employment is contingent upon the successful clearance of a background check.

PREFERRED KNOWLEDGE SKILLS AND ABILITIES

• Master of Science degree in Electrical Engineering.
• Excellent bench skills.
• Proactive approach to problem-solving.
• Detail-oriented and a firm commitment to quality.
• Ability to work in a collaborative, multidisciplinary team environment.
• Problem-solving, data analysis, deductive reasoning, and critical thinking skills.

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Office environment.
• Occasional exposure to heat, cold, and allergens while performing tests or demonstrations in the field.
• While performing the duties of this job, the employee is required to do the following:
  • Lift equipment up to 20 lbs. for the set-up of demonstrations and testing.
  • Perform bending and reaching movements to place items on lower and higher shelves.
  • Kneeling or squatting to access lower shelves.
  • Walking/Moving in the labs

THE OPPORTUNITY

Silvus Technologies is seeking an RF Test Engineer who will report to the Director of RF Engineering on the RF Engineering team. The successful individual in this role will actively participate in all aspects of the testing of RF hardware for Silvus’ StreamCaster MANET product line.  This position is 100% onsite Monday through Friday at our office located in Rancho Bernardo, North San Diego CA. 

The following is a list of at least some of the current essential job functions of the position. Management may assign or reassign duties and responsibilities at any time at its discretion. 

ROLE AND RESPONSIBILITIES

• Using RF test equipment to evaluate system performance, evaluate compliance compatibility and troubleshoot operation issues.
• Carry out RF test execution and generate status and test reports.
• Define verification matrix and internal specifications of RF performance.
• Review test result data to ensure that actual performance meets expected requirements.
• Review and recommend improvements to existing test strategies.
• Recommend new test techniques and technologies to ensure system performance.
• Design test fixtures and calibrate test equipment.
• Understand proper use and handling of sensitive RF circuits and equipment.
• Rare local travel to other company locations, as required (i.e. Irvine, West LA)

REQUIRED QUALIFICATIONS

• Bachelor of Science degree in Electrical Engineering.
• Minimum 2 years of relevant multi-GHz RF hardware test experience.
• Hands-on experience using RF test equipment such as Spectrum Analyzers, Signal Generators, Vector Network Analyzer etc.
• Strong troubleshooting skills.
• Excellent written and verbal communication skills to provide clear summary of test status and any issues to broader team.
• Experienced with component-level RF circuit characterization and optimization.
• Must be a U.S. Person (permanent resident or citizen) due to U.S. government contracts.
• Employment is contingent upon the successful clearance of a background check.

PREFERRED KNOWLEDGE SKILLS AND ABILITIES

• Knowledge of RF guidelines for PCB layout.
• Test automation using Python or LabView.
• Able to work independently and work on several projects concurrently.
• Detail-oriented and a firm commitment to quality.
• Ability to work in a collaborative, multidisciplinary team environment.
• Problem-solving, data analysis, deductive reasoning, and critical thinking skills.

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Office environment.
• Occasional exposure to heat, cold, and allergens while performing tests or demonstrations in the field.
• While performing the duties of this job, the employee is required to do the following:
  • Lift equipment up to 20 lbs. for the set-up of demonstrations and testing.
  • Perform bending and reaching movements to place items on lower and higher shelves.
  • Kneeling or squatting to access lower shelves.
  • Walking/Moving in the labs.

Position Summary: 

Reporting to the CMO, the VP Global Pharmacovigilance has overall responsibility for drug safety activities for early and late phase assets, including furthering the development and implementation of the clinical development strategy. The VP will be accountable for overseeing safety and pharmacovigilance across development and expected global launches and, ultimately, post-marketed products. The VP must possess a strong knowledge of global pharmacovigilance regulations, operational efficiencies, information systems, and best industry practices to effectively solve challenges and facilitate PVG compliance.

Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States.   

Essential Duties and Responsibilities:

• Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy with clinical development.
• Represent GPV in communication with health and regulatory authorities.
• Represent GPV at independent Data Safety Monitoring Committee meetings.
• Provide medical oversight of the GPV function including medical review of all cases.
• Provide medical input for maintaining REMS, RMP safety monitoring commitments.
• In collaboration with other members of GPV, create and maintain a signal detection process for Erasca’s products with a clearly defined signal detection strategy for each asset.
• In collaboration with other members of GPV, ensure robust processes are implemented to meet REMS/RMP commitments.
• Overall responsibility for development and implementation of QPV, in collaboration with Quality and GPV Systems.
• Provide periodic benefit-risk assessment reports for internal use.
• Contribute to the preparation of, review, and approve aggregate safety reports required by health authorities.
• Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc).
• Work with external partners to jointly manage cases, safety reporting, and signal detection across global development for molecule candidates.
• Manage implementation and/or operation of data analytics and data reporting tools to support drug safety compliance and analysis.
• Build and lead highly functioning GPV team including Safety Operations and Safety Science, utilizing internal and external resources.
• Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met.
• Assess process, systems, and staffing needs to scale for multiple late-stage trials, including oversight of CROs and vendors.
• Develop and maintain relationships across Erasca, particularly in Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs.
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Required Education and Experience:

• Doctor of Medicine or x-US equivalent with industry experience in safety science for oncology clinical development required; PharmD or other relevant clinical degree may be considered.
• 12 or more years of experience in the biotechnology or pharmaceutical industry with knowledge of GCP, clinical trial conduct, data interpretation, and safety in clinical development. A mix of large and small company experience highly preferred.
• Excellent scientific and clinical and analytical knowledge base, with the ability to assess data and understand safety and medical implications.
• In-depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation.
• Experience with early clinical development required; experience in late-stage clinical development and NDA or BLA submission preferred.
• Extensive experience interfacing with US (FDA) and x-US health authorities required. Experience executing clinical trials in China, reporting safety data to China health authorities preferred.
• In depth knowledge of Safety Science and Safety Operations disciplines, with exposure to both internally and externally managed safety systems and databases.
• Direct management experience with proven ability to effectively lead, coach, mentor, and manage others.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
• Strong learning orientation, curiosity, and commitment to science and patients.

The anticipated salary range for this position is $370,000 to $390,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.