JOB SUMMARY

Responsible for driving all aspects of the Analytical and Microbiological Quality Control (QC) laboratories at Genezen. This individual provides leadership, scientific and technical expertise for all QC activities, as well as support to Analytical Development for all method qualification/validation activities. This person is also the facility aseptic subject matter expert, including responsibilities for the environmental monitoring program. The ideal candidate must have in-depth knowledge and experience in a cGMP/ GLP testing lab.

ESSENTIAL JOB FUNCTIONS

• Ensure timely in-process and release testing of early clinical grade biopharmaceuticals
• Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, and cell-based assays)
• Monitor, maintain and continuously improve the environmental monitoring program, including conducting Environmental Monitoring Performance Qualifications as needed
• Develop, implement and maintain EM trending program and metrics, including Annual Reports and evaluation of alert levels
• Develop, implement and maintain an in-house isolates program
• Responsible for Disinfectant Efficacy Program
• Responsible for the Analytical laboratory equipment systems and software (e.g., ddPCR, Flow, etc.) including purchase, calibration, IOPQ activities, etc. to meet the compliance (data integrity) requirements and project timelines.
• Support the Analytical Development team in qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
• Support the tech transfer of bioassays from clients to cGMP QC testing lab
• Represent QC Analytical and Microbiological in client meetings and programs
• Establish and maintain the stability program
• Oversee LIMS development, implementation, operation, troubleshooting and maintenance
• Responsible for all laboratory logistics activities including, but not limited to sample management, test/release schedule, cycle time matrix, capacity management, etc.
• Manage outside contract laboratory relationships, including method qualification/validations, investigations, audits, cost and invoices to meet project timelines and business requirements
• Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
• Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of cell and gene products
• Develop, implement and present metrics for monitoring of lab operations and stability program
• Participation in client audits and regulatory inspections as SME and development of responses to observations
• Responsible for hiring and development of team members, conduct performance review and disciplinary actions.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area

 KNOWLEDGE, SKILLS, AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

•  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Senior Technical Transfer Associate (MSAT) is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

The responsibilities:

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross-functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization.  Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, at Simtra, there is a strong emphasis on quality and continuous improvement.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The Principal Technical Transfer Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS. This includes designing the manufacturing process(es) required for drug products. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position reports to the Sr. Manager, Technical Transfer.

What you'll be doing:

• Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies
  • Serve as the lead technical expert among a cross functional team
  • Lead the cross functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Tech. Transfer Plan, process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), demonstration batch records, PPQ master batch record]
  • Heavy participation / co-lead with Process Validation Representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities
• Conduct Non-Conformance Report (NCR) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of fill volume dosing qualifications (FVOQ)
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and ownership of audit responses and related CAPAs]
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• SOP owner & process SME
• Perform filter troubleshooting
• Develops and presents in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services and helps with training and on-boarding
   

What you'll bring:

• BS degree required (preferably in a science or engineering related field
• 6+ years pharmaceutical manufacturing experience (preferably in a CDMO)
• Requires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Experience in aseptic processing, sterile filtration, and process validation
• MS Office Suite advanced proficiency
• Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.)

Physical / Safety Requirements:

• Require overtime work on occasion, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

#LI-SB1

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Manufacturing Science and Technology (MSAT) role is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

The responsibilities:

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross-functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Job Summary: 

Real Chemistry is looking for a Senior Account Manager to join our growing Earned Media team!   

This role can be remote, TX, Carmel, IN, remote FL, remote TN, or remote PA. 

What you’ll do:  

• Prepare well-crafted pitches and strategic media recommendations, integrating PESO and analytics 
• Strategic execution of routine work including media list development, reporter briefing sheets, media audits 
• Able to run and track media projects with limited consultation from senior peers 
• Lead local,tradeand select national/consumer media outreach  
• Maintainand prepare media outreach summaries and updates for internal teams and clients  
• Support organic and new business development efforts (i.e.media research, slide preparation support, etc.) 
• Manage media projects byanticipatingchallenges, maintaining media budgets, and working with cross functional teams  
• Integrate and collaborate with cross-functional leaders (social, paid, search, analytics) 
• Effectively set, manage, and communicate media expectations with team and clients 
• Has general understanding of sponsored opportunities (STAT), influencer programs, and presents opportunities to recommend them 
• Accountable for coaching and developing junior staff 
• Attend client meetings as needed

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  
• You are highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• Bachelor’s degree or equivalent experience
• 3-5 years of relevant experience 
• Excellent project management skills, including solid attention to detail 
• Effective organizational,writtenand verbal communication skills  
• Ability to juggle multiple assignments, meet project deadlines, and effectively communicate shifts in project timeline 
• High-level understanding of how PESO plays out in today’s modern media world 
• Experience with medical meeting support and orchestrating regulatory milestones 
• Thought leadership and sponsored content experience 
• Ability to read new business analytics reports and suggest basic insights for earned mediaportionof pitch  
• Proactive communication across internal and external teams 
• Excellent time management

We are seeking a DevOps Technician with expertise in AWS to join our team. This is a hybrid position that is located in Indianapolis, Indiana. The ideal candidate will be responsible for managing a large and highly distributed computing environment and should possess specialized skills in AWS technologies. This role requires a creative thinker with strong organizational, documentation, and communication skills, capable of operating in a high-security environment where IT security is paramount. The candidate will work closely with other professionals and contribute to the effective deployment and management of systems.

Company Overview
We provide solutions that make a meaningful difference in healthcare. Founded in 1995, MIE serves as the innovation engine for business units that serve hospitals and health systems, physician practices, Fortune 500 employers, government agencies, and consumers. MIE’s web-based health information technology platform is helping physicians, nurses, and administrators make a meaningful difference in healthcare delivery across the globe.

Key Responsibilities

System Management and Automation:

• Prioritize and patch vulnerabilities in a large and diverse computing environment.

• Develop and deploy Ansible playbooks for system automation using GitHub Enterprise.

• Contribute to R&D initiatives, driving innovative solutions.

• Conduct systems analysis to improve operations, recommending changes in technologies and procedures.

• Recommend purchases of hardware, software, and infrastructure for data center operations.

AWS-Specific Responsibilities:

• Manage and optimize AWS resources and infrastructure.

• Utilize AWS services (such as EC2, S3, RDS, Lambda, etc.) for system automation and scalability.

• Implement and maintain AWS security best practices, including IAM policies, encryption, and VPC configurations.

• Monitor AWS environments for performance, cost-efficiency, and security compliance.

Documentation and Training:

• Maintain and create thorough and accurate documentation of systems and procedures.

• Assist with the training and development of team members to enhance their AWS skill sets.

Technology Updates and Security:

• Stay updated on state-of-the-art technologies by continuous learning and research, especially in AWS.

• Protect operations by ensuring the confidentiality of sensitive information.

Required Qualifications

Experience:

• Minimum of 2 years of technical experience in design, system installations, administration, and/or support of critical business systems.

• Proven experience with AWS, including deployment and management of resources in a cloud environment.

• Hands-on experience with CentOS, Debian, RHEL, Ansible, Vagrant, Proxmox, PXE boot, Kickstart, and GitHub.

• Strong Linux administration background and knowledge of data center, networking, and storage solutions.

• Experience with patch management, vulnerability management, and IT lifecycle management.

• Knowledge of network routing and switching, load balancers, firewalls, and various networking systems.

• Excellent communication skills with the ability to work well in a close-knit team.

Skills:

• Proficiency in a wide variety of open-source technologies.

• Advanced troubleshooting skills to drive to root cause.

• Deep understanding of AWS best practices, including infrastructure as code (IaC) with tools such as AWS CloudFormation or Terraform.

• Knowledge of IT operations in an always-up, always-available service.

• Exposure to infrastructure and application security technologies and approaches.

Why Join Us?

At MIE and Enterprise Health, we offer more than just a job. We provide an environment where innovative thinking is encouraged, teamwork is valued, and growth is fostered. Our comprehensive benefits package includes:

• Competitive compensation

• Comprehensive benefits package including medical/dental/vision insurance

• 401k with company match

• Paid-Time off

• Quarterly bonus program

• Flexible work schedule

• Remote work

Medical Informatics Engineering and Enterprise Health are equal-opportunity employers. We celebrate diversity and are committed to creating an inclusive environment for all employees.

RC Resolve is a strategic communications advisory firm working at the intersection of finance, corporate reputation, public affairs, and brand for healthcare companies, backed by the capabilities and expertise of Real Chemistry.  

We partner with boards and management teams during normal course and transformative periods to design communications strategies that help companies advance business goals, build trust, and seize timely market opportunities. We counsel executives and boards through highstakes moments including M&A, IPOs, restructurings, shareholder activism, crises, and major corporate transformations. 

We are seeking a senior leader to build and lead our Financial and Transaction Communications offering, working with clients across sectors and geographies. 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

Role Overview 

The Head of Financial and Transaction Communications will be a senior leader responsible for: 

• Building and leading our financial communications practice 

• Serving as a primary advisor to CEOs, CFOs, General Counsel, Heads of IR, and Boards working in concert with their key advisors 

• Driving new business and deepening relationships with existing clients to support issues and opportunities  

• Leading teams through complex, high-stakes, timesensitive, and confidential situations 

This role suits an experienced financial communications professional from a top-tier advisory firm, inhouse IR/corporate comms team, or similar environment, who thrives in fastpaced, transaction driven work and business- and relationship-building opportunities. 

Key Responsibilities 

Client Advisory & Strategy 

• Serve as trusted counselor to senior executives on all aspects of financial and capital markets communications. 

• Develop and oversee integrated communications strategies around:

• IR Advisory
• M&A
• IPOs and SPACs
• Activist Defense & Preparedness
• Restructuring
• Bankruptcy
• Executive Transitions
• Divestitures & Spins
• Investor and R&D Days
• Financial Media Relations & Storytelling

• Craft clear, compelling narratives that translate complex financial and strategic issues for investors, media, employees, regulators, and other stakeholders. 

• Provide real-time strategic counsel in high pressure, confidential situations, often in partnership with legal and banking advisors. 

Transaction/Event-driven Communications 

• Lead communications workstreams for event-driven situations (to include but not limited to: M&A, IPOs/Spins/SPACs, activism, bankruptcies/restructurings, crisis (cyber, litigation and beyond), Board/management transitions.), including: 

• Prospecting, relationship building with key advisors (bankers, lawyers, etc.) focused on HC sector. 

• Leading transaction / event-driven work. 

• Development of comms strategy, materials, media and social considerations. Support of the lead up to announcement, announcement day as well as integration support. 

• Deal playbook and scenario planning to protect and preserve reputation and valuation throughout the deal process 

• Development of strategy, scenario planning, communications playbook, etc. for lead up to, day of and post-announcement situation  

• Drafting key materials (press releases, Q&As, investor decks, fact sheets, talking points, etc.) 

• Coordinating with key advisors (lawyers, bankers, etc.) and ensure alignment with regulatory and disclosure requirements 

IR Advisory & Related Services 

• Develop and refine clients’ equity story/investor narrative 

• Oversee creation and quality of investor facing collateral, including: 

• Investor presentations 

• Investor day/R&D day materials  

• Infographics 

• IR website alignment with collateral 

• Earnings Advisory: Advise and support the development of earnings materials: to include press release, deck, scripts, Q&A prep  

• Advise on engagement with sellside and buyside analysts in coordination with IR and legal teams. 

• Annual reports as well as sustainability reports (in partnership with design/ESG teams as needed). 

• Advise on integration of financial communications with broader corporate reputation, ESG, and public affairs strategies. 

Financial Media & Stakeholder Engagement 

• Lead financial and business media strategy, cultivating relationships with key journalists and outlets. 

• Prepare executives for highstakes media interviews, investor meetings, earnings calls, and roadshows. 

Practice & People Leadership 

• Build and lead a high-performing financial communications team within the agency, including integration of legacy IR team, recruitment, training, and mentorship. 

• Set practice standards, playbooks, and bestinclass approaches for transaction and capital markets mandates. 

• Foster collaboration across practices (corporate, crisis, public affairs, digital, ESG, brand) to deliver integrated solutions. 

• Contribute to firm leadership, culture, and DEI objectives. 

Business Development 

• Drive growth of the financial communications practice through: 

• Identifying and pursuing new business opportunities 

• Leading and contributing to pitch development and presentations across significant client base 

• Build rapport and become a trusted, go-to referral partner for network among corporates, private equity, banks, law firms, and other advisors. 

• Help shape the agency’s market profile via thought leadership (reports, opeds, conferences, webinars) on capital markets, M&A, activism, and related themes. 

Qualifications 

• 15+ years of experience in financial communications, investor relations, investment banking, equity research, or related fields, with a strong advisory component. 

• Proven track record working on complex, highstakes situations such as: 

• M&A (including crossborder, contested, and private equitybacked deals) 
• IPOs and significant capital markets transactions 
• Shareholder activism and governance/ESG-related campaigns 
• Restructurings, turnarounds, and crisis situations with market impact. 
• Experience in a leading strategic communications/PR firm (e.g., financial/transaction communications practice) or top-tier in-house corporate role strongly preferred.  

• Experience working with healthcare clients a plus      

Skills & Capabilities 

• Deep understanding of capital markets and the needs of institutional investors and analysts. 

• Exceptional writing skills: capable of producing clear, concise, and persuasive materials under tight deadlines. 

• Strong judgment and discretion, with demonstrated ability to advise senior executives and boards in sensitive situations. 

• Comfortable operating in fast-paced, ambiguous, and time pressured environments; calm and solutions-oriented under stress. 

• Strong project and team management skills; able to run multiple complex engagements simultaneously. 

• Collaborative and low ego; able to integrate with cross-functional teams including legal, banking, IR, public affairs, digital, and creative. 

Education & Other 

• Bachelor’s degree required; advanced degree (MBA, JD, or related) a plus but not required. 

• Understanding of US regulatory and disclosure frameworks; global regulatory expertise not required but helpful 

• Willingness to work extended hours during live situations and to travel as required. 

  Pay Range: $300,000 - $360,000

  This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time

Real Chemistry is looking for an Associate Director join our growing Earned Media team!   

This role can be remote, TX, Carmel, IN, remote FL, remote TN, or remote PA.

What you’ll do:  

• Work directly with a variety of clients in the biotech and pharma spaces to manage media strategy, execution and related internal/external media expectations 
• May serve as day-to-day client contact for media needs on select accounts and as a strong #2 on others 
• Manage and own media engagement with local, trade and some national & top-tier media/journalists 
• Track and prepare media outreach summaries/updates for internal teams and clients 
• Support organic and new business development efforts (i.e. media research, slide preparation support, etc.) and actively contribute to new business decks, along with smaller-scale presentations representing earned media team 
• Manage media projects by anticipating challenges, maintaining media budgets, and collaborating with cross functional teams 
• Lead broad-based earned media workstreams and manage internal and external client expectations 
• Maintain core relationships with reporters by meeting regularly and sharing learnings with teams and clients 
• Serve as knowledge relationship manager for key sponsored content outlets (STAT, etc.) and share information more widely 
• Responsible for providing integrated, 360-degree PESO thinking 
• Collaborate with the analytics and influencer teams to identify influencers to engage and activate 
• Accountable for training junior staff on Real Chemistry processes, responsibilities and the healthcare media landscape 
• Integrate and collaborate with cross-functional leaders, understand cross-functional capabilities and motivate cross-functional teamwork(social, paid, search, and analytics teams) 
• Set clear performance objectives and utilize all management tools to communicate alignment and performance measures 
• Embodies and incorporates Real Chemistry Core Values 

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  
• You are highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• Bachelor’s degree or equivalent experience
• Minimum 5 years of relevant experience 
• High-level understanding of how PESO plays out in today’s modern media world 
• Excellent project management skills, including solid attention to detail 
• Highly effective organizational, written and verbal communication skills 
• Ability to juggle multiple assignments with ease and flexibility 
• Can effectively and confidently present to internal and external audiences in a variety of ways 
• Understands how to maintain media budgets and media scopes 
• Demonstrates deep understanding of the integrated media landscape as well as related firm resources (notably analytics) 
• Experience with medical meeting support and orchestrating regulatory milestones 
• Thought leadership and sponsored content experience 
• Able to plan projects and proactively delegate responsibility, communicating deadlines clearly 

Your Role:

As a key member of the sales/commercial team, the Territory Business Manager (TBM) will lead sales at the territory level and serve as the primary liaison between customers and SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany. The TBM will deliver on revenue goals by executing the brand objectives through communication of approved clinical information, rigorous account planning and commercial team collaboration. The TBM will be responsible for appropriately promoting our rare disease product(s) along with implementing programs and initiatives in accordance with the company and industry guidelines.

Location Classification – Field-Based: ​

Officially classified as working as a member of field organization, with the expectation of this role to travel and engage and with external partners, collaborators, and other third parties regularly on behalf of SpringWorks Therapeutics. #LI-Remote

Essential Duties and Responsibilities:

• Maintain an expert operating knowledge of all company policies and guidelines including but not limited to those addressing interactions with Healthcare Professionals, compliance and business conduct.
• Ensure compliance with all Company, industry and government laws or regulations including guidelines pertaining to ethical business practices.
• Accountable for overall territory revenue and customer support.
• Achieve short and long-term sales objectives by identifying customer needs and providing solutions to create a professional relationship between the customer and SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany. in both the live and virtual setting, as well as, within the community/academic setting respectfully.
• Build relationships with key HCP’s, physician practices, and hospitals/clinics, practice managers across various treatment and academic settings, including major cancer centers.
• Be a territory expert having deep market, customer, product, and competitive insights. Understand the changing healthcare landscape and strategically adapt to succeed in a constantly evolving environment.
• Successfully complete ongoing training and development to include product knowledge, selling skills, goal setting, planning and analysis, use of marketing tools and clinical information and sales competencies.
• Strategically identify and enact ways to appropriately put patients and customers first, demonstrating behaviors and prioritizing those tasks which will enable delivery of medicines to patients with greater speed and increase the ability to help patients’ lives.
• Demonstrate strong critical analytic and planning skills in reviewing data, understanding trends, preparing, communicating applicable plans and embracing the digital platforms/omnichannel strategies.
• Fully participate in field coaching sessions, including receiving guidance, positive reinforcement, and corrective action where needed with a focus on the execution of accounts plans and competency development to ensure revenue targets are met.
• Work collaboratively and manage ongoing communication and tactical coordination with field and HQ colleagues.
• Work to support local/area KOL’s.
• Perform other duties and responsibilities as assigned.

Education & Qualifications: 

• Bachelor’s degree required (Advanced degree preferred)
• 7+ years of pharmaceutical and/or biotech experience required
• 5+ years proven Rare Disease sales experience in the pharmaceutical/ healthcare industry with demonstration of successful results
• Oncology experience
• Experience selling in a competitive market
• Experience with virtual selling and track record of embracing technology
• In-depth understanding of the Oncology landscape and market dynamics is highly desirable
• Strong expertise in reimbursement and managed care knowledge
• Possesses high integrity and exceptional work ethic. Fosters mutual trust and respect
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual performance
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
• Ability to travel occasionally including overnight stay driven by business need.

Physical Requirements of Position:

• A valid and active driver’s license
• Position may require domestic travel up to 50% of time
• Candidate must live within the identified territory #LI-Remote

Compensation & Benefits:

The expected salary range for this position is $185,000.00 to $210,000.00. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary incentive compensation is available based on individual performance tied to MBO's and Sales Incentive Plan.

PURPOSE

Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

ESSENTIAL JOB FUNCTIONS / DUTIES

• Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
• Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
• Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
• Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
• Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
• Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
• Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications.
• Review, assess, and release quality control tests and Certificates of Analysis
• Review and approve executed batch records. Provide guidance and support to departments on errors to ensure error reduction.
• Assist in the final disposition of master cell banks and viral vector products.
• Review and approve qualification/validation protocols and reports and technology transfer reports.
• Provides site GMP and GDP training (annually, for new-hires, and as needed).
• Initiate and perform Root Cause Analysis for Quality Events such as Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events.
• Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
• Drive Quality Events to closure within on-time closure deadlines.
• Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products,
• Review and approve Master Batch Records.
• Review and approve Media Fill Protocols and Reports, as well as participate as a Quality observer as needed.
• Review and approve Stability Protocols.
• Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas
• Initiate, review, approve and monitor Change Management activities
• Work with the other functional areas to give guidance on use of quality systems.
• Assist the Lead Auditors to perform site internal audits.
• Lead and/or support customer audits and regulatory inspections by participating in either front or back room.
• Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Occasionally exposed to loud noise levels
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

JOB SUMMARY

Provide maintenance, calibration, and technical support to the manufacturing process and facility equipment.  Coordinate and perform testing and calibration on electrical, mechanical, and analytical equipment for conformance to established standards. Request purchase order requisitions for 3^rd party maintenance requirements.

ESSENTIAL JOB FUNCTIONS

• Assist in creating/establishing a Maintenance and Calibration Program including recommendation of Maintenance and Calibration activities and frequencies based upon system/equipment assessments
• Plan, schedule, and perform planned and unplanned maintenance and calibration on process and facility equipment/utilities including but not limited to HVAC, freezers, cold rooms, bioreactors, filling systems, analytical testing instruments, and building management control systems
• Coordinate and support external calibration service providers
• Build relationships with customers, colleagues, and service partners to provide a collaborative approach to the operational management of lab spaces.
• Track and report on calibration status of all equipment/instruments in the facility
• Ensure timely completion of calibrations/preventive maintenance and compliant record keeping.
• Obtain required documentation and approval prior to creation of purchase order requisition for service requests to be completed by 3^rd party vendors.
• After purchase order has been issued, ensure service delivery dates are correct and revise as necessary, per follow-up with suppliers and customers.
• Source, qualify, negotiate, and procure service contracts in support of lab operations.
• Ensure purchase requisitions are requisitions closed within 180 days and confirm that associated purchase orders are closed as well.
• Enter and maintain records in the Computerized Maintenance Management System (CMMS)
• Meet regularly with key stakeholders (lab staff, service partners, management) to identify, review and resolve issues in a timely manner and/or escalate as necessary.
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

• Associates Degree
• Bachelor's degree 
• EET
• 3-5 years related Calibration/Metrology work experience
• Ability to understand user manuals/specifications, wiring diagrams, equipment Piping & Instrumentation Diagrams (P&ID), and Standard Operating Procedures (SOP)
• Mechanically inclined/knowledge of hand tools
• Proficient with advanced computer systems including the use of a CMMS
• Excellent interpersonal skills and communication skills with ability to act as a change agent

PHYSICAL DEMANDS

The physical demands described here are representative of those 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.

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication 

• Frequently required to communicate by talking, hearing, using telephone and e-mail