POSITION OVERVIEW:

As the Sr. Director/Vice President, Artificial Intelligence, you will lead the strategic development and enterprise-wide adoption of AI capabilities that support organizational transformation. Your role involves defining the AI vision, building a scalable roadmap, and driving execution across multiple business units. You will partner with Technology, Operations, Product, and executive leadership to identify high-value use cases, develop AI solutions, and integrate them into core business processes to deliver measurable results. This position requires a high level of autonomy, technical expertise, and strategic leadership, including assessing business needs, ensuring data readiness, designing and deploying models, overseeing MLOps practices, and implementing responsible AI principles. Your experience in AI, machine learning, data strategy, communication, stakeholder alignment, and solution delivery will be essential in enabling the organization’s transformation goals.

JOB FUNCTIONS:

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

• Lead the strategic planning, development, and execution of the company’s AI roadmap and long-term innovation strategy.
• Identify, evaluate, and prioritize AI and machine learning opportunities that improve operations, automation, and business value.
• Apply structured methodologies to assess use case feasibility, technical readiness, adoption requirements, and expected ROI.
• Partner with Data Engineering and Technology teams to build and deploy scalable AI models, generative AI capabilities, and decision intelligence tools.
• Oversee all stages of the AI development lifecycle, including model design, testing, deployment, monitoring, retraining, and performance optimization.
• Develop and manage responsible AI frameworks that address transparency, risk, ethics, compliance, and governance.
• Conduct impact analyses and assess organizational readiness to adopt AI-driven processes and technologies.
• Create and deliver communication strategies to support AI adoption for leaders, teams, and stakeholders.
• Collaborate with business units to map workflows, redesign processes, and integrate AI-driven solutions into operations.
• Lead the design and implementation of training programs that support end-user adoption of AI tools.
• Build, develop, and mentor a high-performing AI organization across data science, machine learning, and applied AI disciplines.
• Partner with external technology providers, vendors, academic institutions, and research organizations to evaluate emerging AI technologies.
• Create metrics and dashboards to measure activation, performance, and business impact of AI solutions.
• Lead continuous improvement efforts through data analysis, root cause assessment, and iterative solution updates.
• Communicate complex technical concepts and model insights to executive leadership in clear, accessible language.
• Manage AI program budgets, resources, vendor contracts, and reporting requirements.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s degree in Computer Science, Engineering, Data Science, or a related technical field required.
  Advanced degree preferred.

Technical Experience:

• 12 to 15 or more years of experience in AI, machine learning, data science, or advanced analytics.
• Demonstrated experience building and deploying machine learning models and generative AI systems in production environments.
• Deep understanding of modern AI techniques including large language models, natural language processing, deep learning, predictive modeling, and reinforcement learning.
• Experience implementing MLOps pipelines, model governance, and scalable AI systems in cloud environments such as Azure, AWS, or Google Cloud.
• Experience leading organization-wide AI or data transformation initiatives.
• Experience managing cross-functional teams and external partners or vendors.

Knowledge, Skills, and Abilities:

• Ability to define AI strategy, scope work, estimate effort, and drive execution.
• Ability to explain technical concepts to non-technical audiences and communicate with executives.
• Strong knowledge of AI ethics, responsible AI practices, and regulatory considerations.
• Ability to lead teams, influence stakeholders, and guide cross-functional efforts toward a shared vision.
• Strong analytical and problem-solving skills with the ability to interpret complex data and model results.
• Ability to manage multiple priorities in dynamic and fast-paced environments.
• Forward-thinking mindset with a focus on innovation and continuous learning.
• Strong presentation skills and experience delivering training or communication materials.
• Must be legally authorized to work in the United States without employer sponsorship now or in the future.

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.

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:

The Project Manager is responsible for guiding clients through the development, installation, and execution of comprehensive Operational and Business Excellence programs. This role leads the delivery of a continuous improvement and organizational change framework that enables clients to adopt a common language, processes, tools, and systems that drive sustainable transformation.

KEY RESPONSIBILITIES:

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

• Lead, deploy, and strengthen client capabilities to establish holistic Business and Operational Excellence programs.
• Serve as a strategic partner to client leadership, contributing to organizational goals, transformation roadmaps, and long‑term strategy execution.
• Translate strategic objectives into actionable operational goals and structured improvement initiatives.
• Support the definition and evolution of organizational structures, roles, and governance models that enable Operational Excellence and change adoption.
• Provide leadership in shaping, communicating, and reinforcing a strategic vision for Business Excellence across client organizations.
• Develop and manage transformation roadmaps in partnership with cross‑functional client teams, ensuring alignment, prioritization, and measurable outcomes.
• Coach leaders and teams on structured problem‑solving methodologies (Lean, Six Sigma, etc.) and change management practices.
• Collaborate with internal and external stakeholders to ensure alignment with program strategies, change impacts, and organizational readiness.
• Track and influence key success measures including team engagement, Operational Excellence maturity, Lean Six Sigma capability development, and measurable improvements in quality, cost, and delivery.
• Apply business excellence methodologies across diverse environments including operations, labs, engineering, administrative functions, and other business processes.
• Support organizational change management activities such as stakeholder engagement, communication planning, readiness assessments, and adoption tracking.
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

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 or Master’s degree (preferred) in a related technical and/or business discipline or equivalent experience.

Technical Experience:

• Minimum of 9–15 years of demonstrated leadership in the medical device industry or a directly related field.
• Certified Lean Six Sigma Black Belt or equivalent, with extensive project experience applying LSS methodologies.
• Strong background in holistic operational excellence frameworks, continuous improvement systems, and associated tools/techniques. 
• Experience leading organizational change initiatives, including communication, stakeholder management, and adoption planning.

Knowledge, Skills, and Abilities:

• Comfortable guiding teams and leaders at all levels through operational excellence and organizational change.
• Dynamic and engaging facilitation and training skills.
• Strong coaching and mentoring capability, particularly in problem‑solving and change leadership.
• Ability to simplify and communicate complex concepts clearly and effectively.
• Self‑starter who works independently, maintains a positive attitude, and drives momentum. Knowledge of and compliance with applicable Quality System requirements.
• Ability to thrive in a fast‑paced environment while managing multiple priorities.
• Flexible, adaptable, and able to operate both 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.

COMPENSATION:

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $170,000 yearly in our lowest geographic market up to $180,000 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job‑related knowledge, skills, and experience.

Applicants must have current work authorization when accepting a position at Syner‑G. 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:

The Lead Generation Specialist I plays an important role in advancing Syner-G’s growth objectives by supporting and executing lead generation strategies that build brand recognition, expand market presence, and contribute to client acquisition initiatives. This position provides an opportunity to exercise discretion and independent judgment in research, outreach approaches, and campaign execution, while gaining exposure to business development strategy in the life sciences industry.

WORK LOCATION:

 The Lead Generation Specialist I position is eligible for remote work based on company requirements, with no minimum in-office requirement.  

KEY RESPONSIBILITIES:

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

• Conduct research and analysis to identify prospective accounts, key decision-makers, and emerging opportunities.
• Apply independent judgment in tailoring outreach strategies (email, telephone, and digital platforms) to effectively engage prospective clients.
• Collaborate with Marketing and Business Development Leads to design and refine campaign messaging that supports consultative selling.
• Assist in evaluating market trends and client challenges to recommend approaches for positioning Syner-G as a solution provider.
• Maintain Salesforce pipeline ownership at the entry level, ensuring accurate tracking, insight generation, and reporting of lead development activities.
• Summarize findings from outreach efforts and provide strategic recommendations to Business Development Leads to inform ongoing market engagement.
• Contribute to team discussions on lead generation tactics, offering insights from research and campaign outcomes.

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 or Equivalent job-related experience preferred

Technical Experience:

• Minimum of 1-2 years’ successful experience working in lead generation or sales roles in a scientific space OR Master’s degree in life sciences / biotechnology
• Strong analytical and research skills, with the ability to identify patterns and draw conclusions to guide outreach strategies.
• Excellent communication skills, both written and verbal; ability to build a genuine rapport with prospects in virtual settings
• Ability to come up to speed quickly and manage multiple projects / priorities
• Driven / resourceful to find winning approaches to effectively deliver messages to prospective customers that resonate
• Ability to comprehend and communicate scientific verbiage and concepts

Knowledge, Skills, and Abilities:

• Enthusiastic team player with exceptional communication skills able to navigate selling hurdles, understand different buying personas, position, and communicate the value of Syner-G’s solutions, and persuade new business prospects to learn more 

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.

Applicants must have current work authorization when accepting a position at Syner-G. 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:

Syner-G is seeking a Sr. Program Manager (construction) to provide executive-level leadership, strategic direction, and oversight across large, complex capital programs involving multiple projects, cross-functional workstreams, and diverse stakeholder groups. This role is responsible for establishing and maintaining program governance, driving organizational alignment, managing program-level risks and financials, and ensuring capital initiatives are delivered safely, efficiently, and in accordance with regulatory and business requirements. The Sr. Program Manager serves as a trusted advisor to client leadership, guiding long-term capital planning, execution strategy, and continuous improvement across the program lifecycle.

WORK LOCATION:

Travel to client sites may be required based on project demands and client expectations.

KEY RESPONSIBILITIES:

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

• Provide senior-level leadership and direction across complex capital programs, ensuring alignment with organizational strategy, technical requirements, and client objectives.
• Develop and oversee program governance structures, communication frameworks, reporting systems, and decision-making processes.
• Lead program planning activities including scope definition, prioritization, resource planning, and long-range capital forecasting.
• Oversee program schedules, milestones, interdependencies, and resource allocation across multiple concurrent projects.
• Identify and manage program-level risks, issues, and constraints, ensuring mitigation strategies are developed and implemented.
• Coordinate and align cross-functional teams including engineering, construction, operations, procurement, finance, quality, and safety.
• Review and approve program documentation including design packages, technical deliverables, construction plans, and compliance documentation.
• Facilitate communication between internal teams, external partners, contractors, and executive stakeholders to ensure clarity and alignment.
• Lead executive-level program reviews, steering committee meetings, and strategic planning sessions.
• Ensure program activities comply with applicable codes, standards, regulatory requirements, and internal procedures.
• Oversee program budgets, forecasts, financial performance, and cost-control strategies.
• Manage program-level change control processes, ensuring impacts are evaluated, documented, and communicated.
• Support commissioning, qualification, and operational readiness activities across the program.
• Prepare program reports, dashboards, and executive summaries to communicate progress, risks, and performance indicators.
• Drive continuous improvement initiatives, organizational learning, and long-term capital program optimization.
• Provide mentorship and leadership to project managers, engineers, and program support staff.

QUALIFICATIONS AND REQUIREMENTS:

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

Education:

• Bachelor’s degree in engineering, construction management, project management, or a related technical field preferred.
• PMP, PgMP, or similar program management certification is strongly preferred.

Technical Experience:

• 7-15 years of experience in capital project management, program management, engineering leadership, or related roles.
• Extensive experience managing large-scale capital programs involving multiple projects, stakeholders, and technical disciplines.
• Experience working in regulated or complex environments such as biotech, pharmaceutical, industrial, or advanced manufacturing.
• Deep understanding of capital project lifecycles, design coordination, construction execution, commissioning, and operational readiness.
• Experience with program governance, risk management, resource planning, financial oversight, and executive communication.
• Proven ability to lead cross-functional teams and manage complex stakeholder environments.

Knowledge, Skills, and Abilities:

• Exceptional leadership and communication skills with the ability to influence at all organizational levels.
• Proficiency with program and project management tools, scheduling software, and reporting platforms.
• Strategic thinker with strong analytical, organizational, and problem-solving skills.
• Ability to manage multiple priorities and drive program execution in fast-paced, dynamic environments.
• Ability to build and maintain strong relationships with clients, stakeholders, and cross-functional partners.
• Ability to lead through ambiguity and guide teams toward clear, actionable outcomes.

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:

The Global Regulatory Lead Partner supports Global Regulatory Leads in assigned therapeutic areas and serves as the accountable global regulatory point of contact for designated products. The individual provides regulatory leadership for life‑cycle management, maintenance of established products, and execution of global regulatory submissions. This role drives results through regulatory science expertise, strong communication, and analytical capabilities, ensuring high‑quality regulatory strategies and deliverables for assigned products.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

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

• Ensure maintenance of global registrations for assigned products, including US and EU markets.
• Lead and execute regulatory activities supporting life‑cycle management, including submission strategy development, timeline definition, prioritization, assembly review, and identification of regulatory risks/challenges.
• Manage regulatory agency communications and submissions, including responses to agency questions, labeling negotiations, updates, and periodic reports.
• Coordinate SMEs to develop response strategies and author/review responses to health authority requests.
• Support labeling discussions, updates, and filings across CCDS, USPI, SmPC, and country‑specific labels.
• Provide regulatory input for annual reports, renewal applications, and aggregate safety reports (e.g., PSURs, PADERs).
• Conduct regulatory review for tender bid applications and assess country requests for registration deletions.
• Support preparation of ancillary documents required for product registrations in global markets.
• Follow through on agency commitments and ensure timely, high‑quality regulatory deliverables.
• Conduct research and review of US, EU, and other relevant regulatory guidelines, precedence, and competitive intelligence to inform regulatory strategy.
• Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, and other functional partners to ensure alignment and execution of regulatory strategy.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor's degree or higher in a relevant field such as pharmaceuticals, chemistry, or regulatory affairs.

Experience:

• 5+ years of experience in regulatory affairs and/or regulatory framework of major health authorities
• Experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics. Has sufficient regulatory knowledge to integrate inputs from other countries/regions to develop a global strategy and can develop and lead execution of holistic regulatory strategy while considering risk/opportunity, timeline, resource.
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends. Understands scientific and clinical data sufficiently to ask questions and make suggestions about cross-functional topics to influence overall development strategy and to assess regulatory implications and develop regulatory strategy.
• Regulatory experience with pre and post approval lifecycle management, interactions with Health Authorities, leading cross-functional regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Strong strategic skills and the ability to balance short-term needs with long-term vision.
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Skills and Attributes:

• Excellent written and verbal communication skills.
• Strong negotiating skills and ability to think creatively and develop innovative solutions.
• Strong organizational and project management abilities.
• Strong analytical skills with high attention to detail.
• Understanding of regulatory filing requirements.
• Knowledge of ICH guidance and routine regulatory maintenance requirements.
• Ability to manage multiple priorities and work independently in a fast-paced environment.
• Proactive, detail-oriented, and self-motivated with a strong work ethic.

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. 

POSITION OVERVIEW: 

We are seeking a Facilities Technician II 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.

SHIFT:

3 days on, 4 days off; 4 days on, 3 days off; working every other weekend. 7pm-7am ET.

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:

• High school diploma with technical certifications or vocational training. Equivalent on‑the‑job or military technical experience may be considered.

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.

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 employer. 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:
Syner-G is seeking a Sr. Automation Engineer with 7–11 years of experience and strong hands-on expertise in Ignition SCADA, PLC-level programming (Rockwell and/or Siemens), and exposure to modern digital or MES-lite system architectures. This role leads the oversight, documentation, and lifecycle management of automation and digital systems in GMP-regulated environments. The Sr. Automation Engineer will act as a senior technical authority, driving automation strategy, ensuring system reliability and compliance, and supporting complex troubleshooting and integration efforts across client engagements.

WORK LOCATION: Travel to client sites may be required up to 100%, depending on project needs and client expectations.

KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.)

• Lead development, maintenance, and review of automation system documentation, including SOPs, design documents, and lifecycle deliverables such as DS, FS, CA, RTM, and RA.
• Oversee system lifecycle activities, periodic reviews, and audit readiness aligned with regulatory expectations and industry best practices.
• Author, review, and execute complex validation documentation including IOQs, engineering tests, protocols, and summary reports.
• Drive CSV and SDLC processes with strong traceability, risk assessments, and compliance rigor.
• Perform advanced data and system reviews, including alarm rationalization, user access audits, and performance evaluations.
• Own and manage automation-related change records, including impact assessments, stakeholder coordination, and documentation updates.
• Oversee and coordinate maintenance activities, work orders, and system enhancements across automation and digital platforms.
• Collaborate with internal teams and external vendors to resolve complex issues, support upgrades, and implement system improvements.
• Serve as a senior liaison between Facilities, Quality, IT, Operations, and external partners.
• Mentor junior and mid-level automation staff, providing technical leadership and oversight. 
• Lead audit preparation activities and ensure systems remain inspection-ready at all times.
• Provide subject-matter leadership in Ignition SCADA configuration, scripting, module management, and integration with PLCs and MES-lite systems.
• Support PLC and SCADA programming, troubleshooting, and optimization across Rockwell, Siemens, and related control platforms.
• Contribute to digital transformation initiatives, including MES-lite deployments, data modeling, historian integration, and OT/IT convergence efforts.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• BS or MS in Engineering, Life Sciences, or a related technical field preferred.

Experience: 

• 7–11 years supporting and leading automation initiatives in GMP-regulated biotech or pharmaceutical environments.
• Hands-on experience with Ignition (Inductive Automation) for SCADA/HMI development, scripting, gateway configuration, and system integration.
• PLC-level programming experience with Rockwell ControlLogix or CompactLogix and/or Siemens S7 or TIA Portal.
• Experience with BAS/BMS, EMS, or process automation platforms such as Siemens Desigo, DeltaV, Rockwell, or PLC/SCADA systems.
• Exposure to modern digital or MES-lite stacks such as Ignition Perspective, Sepasoft modules, lightweight MES workflows, data lakes, or historians.
• Extensive background in GMP documentation, validation, and CSV/SDLC processes.
• Demonstrated ability to lead technical efforts, manage complex automation projects, and support SMEs through strong documentation, coordination, and compliance execution.

Technical Skills:

• Strong understanding of automation system architecture, control logic, alarm logic, and point configuration review.
• Strong Ignition development skills including Vision or Perspective, scripting, UDTs, tag structures, and gateway configuration.
• Advanced skill in writing, reviewing, and managing controlled documents and validation protocols. Strong leadership, communication, organization, and cross-functional coordination abilities.
• Ability to manage multiple high-priority tasks in a fast-paced, compliance-driven environment.

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.

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. 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:

The Vice President, Regulatory Partnerships is a senior leadership role within the end-to-end Regulatory Strategy organization, spanning preclinical, clinical, Regulatory CMC, Regulatory Operations, and Regulatory Partnerships. This role is responsible for leading and expanding strategic regulatory partnerships, with a strong emphasis on post-approval lifecycle management, driving integrated client solutions, and accelerating commercial growth.

This leader will play a pivotal role in shaping how regulatory services are delivered across the organization by connecting scientific expertise with strategic advisory and execution, while positioning the company as a trusted partner to global pharmaceutical and biotech clients. A key focus of the role will be optimizing post-approval strategies, enhancing client delivery models, driving efficiencies, and embedding continuous improvement across engagements.

KEY RESPONSIBILITIES:

Strategic Leadership and Organizational Impact

• Lead the Regulatory Partnerships function as a core component of an integrated, end-to-end Regulatory Strategy organization
• Define and execute the strategic direction for partnerships, including post-approval and lifecycle management capabilities, ensuring alignment with broader business goals
• Build, lead, and develop a high-performing global team across the United States, India, and evaluate entry into Europe
• Partner across Regulatory Consulting, Regulatory CMC, Regulatory Operations, and other service lines to deliver seamless, client-centric solutions
• Builds a culture of rigor and accountability by establishing clear performance metrics, KPIs, and standardized processes across regulatory partnerships, enabling consistent measurement of delivery quality, efficiency, and client outcomes.

Commercial and Business Acumen

• Drive revenue growth through expansion of strategic client partnerships and development of new business opportunities, including post-approval lifecycle services
• Act as a commercial leader, contributing to pipeline development, account strategy, and revenue forecasting, in consultation with the Commercial team
• Collaborate with Commercial and Business Development teams to shape go-to-market strategies and differentiated service offerings
• Identify opportunities to expand client engagements through lifecycle management, regulatory optimization, and long-term partnership models
• Monitor industry trends, competitive landscape, and evolving regulatory requirements to inform growth strategy

Client Leadership and Partnership Excellence

• Serve as an executive sponsor for key global client relationships
• Lead and manage strategic client partnerships with a focus on long-term lifecycle support, including post-approval activities (variations, supplements, global submissions)
• Build and sustain value-driven relationships with senior client stakeholders across regions
• Ensure consistent, high-quality delivery across engagements, with a focus on scalability, predictability, and client satisfaction
• Leverage client insights and engagement learnings to continuously refine delivery models and strengthen partnerships

Operational Excellence, Efficiencies, and Continuous Improvement

• Drive operational efficiencies by standardizing processes, tools, and delivery models across regulatory partnerships
• Capture and implement learnings from client engagements to enhance quality, consistency, and speed of delivery
• Establish best practices for global post-approval lifecycle management and submission strategies
• Partner with internal teams to optimize resource models, utilization, and delivery effectiveness
• Embed a culture of continuous improvement, innovation, and knowledge sharing
• Leverages data and insights to drive decision-making, continuously refine delivery models, and ensure transparency and alignment across global teams.

Technical and Functional Expertise

• Provide deep expertise across global regulatory frameworks, including FDA, EMA, and other international health authorities, with a strong focus on post-approval requirements
• Guide teams on complex regulatory strategies across the full product lifecycle
• Maintain oversight of quality, compliance, and consistency across all client deliverables
• Contribute to thought leadership, innovation, and advancement of regulatory strategy capabilities

Global Leadership and Cultural Agility

• Lead and develop globally distributed teams, with direct experience across the United States, India, and Europe
• Demonstrate strong cultural awareness and adaptability, enabling effective collaboration across diverse teams and client environments
• Navigate the complexities of global client delivery, recognizing that client partnerships span multiple regions, regulatory bodies, and cultural contexts
• Align global teams to shared goals while respecting regional differences in communication, decision-making, and execution
• Evaluate and, if needed, support expansion into European markets, with an understanding of regional regulatory dynamics and business opportunities
• Foster an inclusive, high-performance culture that promotes accountability, engagement, and excellence across geographies

QUALIFICATIONS & EXPERIENCE:

Education

• Bachelor’s or Master’s degree in Biology, Chemistry, or a related scientific field required

Experience

• 15+ years of progressive experience in Regulatory Affairs, including significant experience in post-approval and lifecycle management
• Demonstrated experience working with the U.S. Food and Drug Administration and strong knowledge of European regulatory frameworks
• Proven experience working within both large pharmaceutical organizations and scientific consulting environments
• Track record of leading and scaling global teams across the United States, India, and Europe
• Strong commercial acumen with demonstrated success in driving revenue growth and expanding client accounts
• Experience leading complex global client engagements and managing senior stakeholder relationships
• Demonstrated ability to drive operational efficiencies, standardization, and continuous improvement
• Experience supporting or leading global regulatory partnership models or FSP-style engagements preferred

Leadership Profile

• Strategic, enterprise thinker with the ability to connect regulatory expertise to business growth
• Commercially driven with strong business and financial acumen
• Client-focused leader who builds trusted advisor relationships
• Collaborative operator who thrives in a matrixed, global organization
• Proven people leader with the ability to develop, inspire, and retain high-performing teams
• Highly adaptable, with strong executive presence and ability to influence across all levels of the organization

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.

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. 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 dynamic and motivated Regional Director of Technical Operations, Southeast to lead our operations and growth strategy in the Raleigh-Durham area, with accountability for performance and client satisfaction across a diverse portfolio of technical projects. This role is responsible for developing and executing the regional account strategy, building and leading teams, and fostering a culture of delivery excellence. 

WORK LOCATION:

Travel to client sites may be required based on project demands and client expectations.  

KEY RESPONSIBILITIES:

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

Account Management and Delivery:  

• Leads a high-performing engineering organization responsible for the successful operational delivery of projects across the regional portfolio of client projects.  

• Acts as a true partner in meeting the needs of clients’ business. Must listen, be passionate about exploring opportunities, and solve client problems proactively on an ongoing basis.  

• With partners in Commercial, develop and executes the regional account strategy, including proactive client retention and expansion as well as identifying and supporting development of new business.  

• Engages in active participation in the RTP life sciences community with an established network of professional relationships.  Drives visibility through industry events, social media, and other marketing initiatives and engagement opportunities.  

Business Acumen and Collaboration:  

• Builds productive relationships with Commercial, Marketing, and other functions (HR, Finance, Talent Acquisition) to support delivery of services to the customer and minimize risk to the business.  

• Partners with other service delivery groups to identify and pursue cross-sell opportunities outside of Technical Operations.  

• Develops annual operating budgets and periodic forecasts, manages regional P&L to meet regional and company goals.  

Leadership:  

• Builds, develops, and mentors a high-performing engineering organization focused on technical competence and proactive service to the client.  

• Works to elevate the way our teams think and operate, creating a culture that results in an engaged workforce.   

• Creates an environment of inclusion and recognition that emphasizes development and reinforces the commitment to our people as our most important asset.  

QUALIFICATIONS AND REQUIREMENTS:

Education:  

• Bachelor’s degree in Engineering, Operations, or related field or equivalent experience with strong business and financial aptitude; MBA desirable  

Experience:  

• 10-15 years of overall life sciences industry experience. 

• 5-10 of experience in project delivery, engineering operations or technical program management.  

• 5 or more years of leadership in GMP manufacturing facility design, construction, startup, engineering, and/or operations.  

• Demonstrated business development success, with the ability to sell services and expand client relationships in a competitive environment.  

• Strong experience in one or more of the following areas: Capital Projects, Facilities Engineering, Process, Automation, CQV, and/or Project Management.  

• Ability to build, develop, and motivate high-performing teams to support and deliver multiple projects under demanding timelines.  

• Proven track record of project delivery for laboratory and/or manufacturing facilities and operations in regulated industries such as biotech, pharmaceuticals, or advanced therapeutics.  

• Exceptional customer relationships and client management skills.   

• Excellent communication, leadership, and organizational skills.   

Preferred Qualifications: 

• Prior experience working as a consultant or managing a portfolio of client projects. 

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.

Applicants must have current work authorization when accepting a position at Syner-G. 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. Process Engineer with a strong background in mechanical or manufacturing engineering and hands-on experience in automated manufacturing environments, preferably within the life sciences industry. The ideal candidate will have demonstrated expertise in engineering gap assessment, 2D drafting, 3D modeling, and equipment design and installation, with a preference for experience in fill-finish lines and filling, capping, and labeling equipment. Familiarity with PLCs and HMIs is required, though this is not a controls engineering role. Proficiency in AutoCAD, SolidWorks, and the MS Office suite (Word, Excel, Outlook, SharePoint) is essential.

WORK LOCATION:

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

KEY RESPONSIBILITIES:

• Lead and support process engineering activities including design, development, and optimization of automated manufacturing systems
• Deliver line layouts and custom fixtures for modification of existing equipment and manufacturing lines
• Generate diagrams, URS, SOPs, and Work Instructions for specification, procurement, installation, and operation of manufacturing equipment
• Effectively communicate site, equipment, and product requirements with vendors and third-party contractors to support project execution
• Manage small to mid-sized engineering projects, ensuring cross-functional collaboration and effective communication between engineering, automation, Quality, and Validation teams
• Support CQV as SME for facilities, utilities, equipment, and process
• Conduct risk assessments and feasibility reviews to ensure compliance with manufacturing and regulatory requirements
• Ensure adherence to cGMP, FDA regulations, and industry standards

QUALIFICATIONS & REQUIREMENTS:

Education:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related technical field

Technical Experience:

• 4 to 7 years of engineering experience in automated manufacturing, preferably in life sciences or biopharma 
• Experience with high-speed fill-finish lines and filling/capping equipment is a plus

Knowledge, Skills, and Abilities:

• Proficient in AutoCAD and SolidWorks Familiarity with PLCs and HMIs Experience with cGMP manufacturing in FDA-regulated environments
• Knowledge of cGxP quality systems and applicable regulatory standards
• Proficient in MS Office, MS Project, and Visio Knowledge, Skills and Abilities: Strong project management and cross-functional communication skills
• Innovative problem-solving and technical analysis capabilities
• Ability to work hands-on in a fast-paced, regulated environment 
• Willingness to travel to client sites as needed

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.

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. 

Don't see a specific job that aligns with your skillsets? Our team would love to connect for future opportunities. Please apply here, and the team will be in touch when we have a position that aligns.

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:

Syner-G seeks a Manager/Senior Manager of Regulatory Affairs to provide regulatory consulting to a large, global pharmaceutical Client in the areas of Chemistry, Manufacturing, and Controls (CMC), to ensure compliance with FDA, EMA, and global regulatory requirements (with a focus on post-approval).  A successful candidate will have a proven track record of applying scientific principles to solve challenges.

WORK LOCATION:

Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations.

KEY RESPONSIBILITIES:

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

• Demonstrating strong ownership, initiative and accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
• Actively contributes to strategic discussions and decision-making processes.
• Possesses excellent communication skills, exhibit strong leadership potential in multicultural settings and ability to communicate complex issues in a succinct and logical manner.
• Contribute to the development of CMC regulatory strategies and submission documents for post approval pharmaceutical products with the ability to execute tasks independently in accordance with US, EMA & global regulations and ICH guidance.
• Execute regulatory strategies by leading the authoring and review of global CMC submissions and ancillary documentation to support post-approval supplements/variations, and responses to health authority questions using established business process and submissions tools.
• Collaborate with CLIENT and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Coordinate timely and accurate responses to the Regulatory agency questions (RTQs) on CMC content.
• Responsible for regulatory operational activities including organizing, tracking, and sending submissions for publishing for the US and other International Markets.
• Provide regulatory change control assessments and strategize post-approval implementation and applicable regulatory reporting.
• Perform regulatory reviews of technical/development documents such as certificate of analysis (CoA), analytical test methods, specifications, and stability protocol/report/data.
• Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product.
• Author/compile documentation for regulatory submission packages including post approval submissions, information request updates, and new markets registration, source of supply changes for submission to global regulatory agencies.
• Proactively ensure all regulatory documents are prepared accurately and completed in a timely manner towards project completion.
• Maintains knowledge of current FDA, EU, global regulations and guidance’s applicable to marketed products.
• Assess and communicate potential regulatory risks and product mitigation strategies.
• Identify, communicate and escalate potential regulatory issues to concerned CMC team/management, as needed.
• May manage a team of two (2) to four (4) individual contributors in support of project execution.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
• Potential for pre-approval submissions (IND/CTA/IMPD) authoring depending upon prior experience and expertise.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s or Master’s degree required in sciences, Pharmacy, Biological sciences, Engineering, or related field, Advanced degree preferred.

Experience:

• Minimum seven (7) years of CMC post approval submissions or relevant experience, which may include regulatory, research, manufacturing, analytical methods development, quality control, or related fields.
• Minimum 5 years’ experience in post approval CMC authoring and review of CMC sections in Module 1, 2, and 3 for the post-approval regulatory filings required.
• Demonstrated superior oral and written communication skills, as well as interpersonal skills; detail-oriented and well organized.
• Working knowledge of the US and European regulations and ICH guidances.
• Extensive knowledge of pharmaceutical development, specifications, release and stability of drug products and substances.
• Strong knowledge and experience of working in cGMP environment preferred.
• Hands on experience in regulatory systems and tools for authoring and change controls assessment is a plus (i.e. EDMS, Veeva Vault, Trackwise).
• Demonstrated ability to prioritize and handle multiple projects simultaneously.
• Proactive and self-motivated; ability to take initiative.
• Strong work ethic and desire to thrive in a fast-paced, deadline-driven environment.
• Prior Supervisory experience in pharmaceutical industry is a plus.

Skills and Attributes:

• Excellent written and verbal communication skills
• Strong organizational and project management abilities
• Ability to manage multiple priorities and work independently in a fast-paced environment
• Proactive, detail-oriented, and self-motivated with a strong work ethic

POSITION OVERVIEW:

The MWS Consultant I plays a critical role in authoring and managing regulatory documents, supporting client regulatory strategies, and ensuring high-quality deliverables that align with client expectations and regulatory standards. This role is responsible for leading document development efforts, coordinating regulatory projects, and collaborating with cross‑functional teams to meet diverse client needs across varying stages of development. The MWS Consultant serves as both a technical contributor and project owner, ensuring document accuracy, submission readiness, and adherence to regulatory requirements while maintaining strong client relationships and delivery excellence.

WORK LOCATION:

The MWS Consultant I position is eligible for remote work based on company requirements, with no minimum in-office requirement. 

KEY RESPONSIBILITIES:

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

• Author a variety of regulatory documents, including Clinical Study Reports (CSRs), study protocols, and client submission materials. 

• Lead the development of complex modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications). 

• Apply quality control and submission-readiness processes to deliver high-quality documents within agreed client timelines. 

• Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands. 

• Plan for and anticipate project challenges, update visual timelines, and maintain adherence to deadlines. 

• Facilitate client interactions, including meetings, inquiries, and feedback discussions, while building and maintaining client trust. 

• Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards. 

• Collaborate with cross-functional teams to ensure the quality and accuracy of regulatory documents. 

• Contribute to the development of regulatory strategies for early-stage and smaller clients. 

• Provide guidance on tools, document management systems, and client SOPs. 

• Engage in continuous learning through exposure to new document types, processes, and industry best practices under senior mentorship. 

QUALIFICATIONS AND REQUIREMENTS:

Education: 

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred. 
• RAC certification is beneficial. 

Technical Experience: 

• 3+ years industry experience 

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Teams, and MS Project. 

• Familiarity with regulatory document management systems, such as Veeva Vault. 

• Experience with regulatory submissions and understanding of global regulatory standards. 

Knowledge, Skills, and Abilities: 

• Strong foundation in medical writing, regulatory writing, and interpretation of scientific content. 

• Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions. 

• Effective written and verbal communication skills, with the ability to communicate complex scientific and regulatory information clearly and concisely. 

• Exceptional project and time management skills, with the ability to prioritize multiple projects and adjust timelines proactively. 

• Patient and empathetic approach, especially in cross-cultural and client-facing environments. 

• Positive attitude toward feedback and a willingness to apply it for continuous improvement. 

• Strong critical thinking and data analysis skills to ensure scientific claims align with evidence and regulatory requirements. 
• High attention to detail, ensuring alignment and accuracy across multiple document reviews. 

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 or hybrid work options for some roles.  However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.  Additionally, our Technical Operations team regularly work at physical client sites.

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.