Boston, Massachusetts, United States · Hybrid
$122k–$153k/yr
About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the indus…
Skills: GMP Quality Assurance, CMC Development, CDMO Auditing, Batch Release, Regulatory Compliance
Danvers, Massachusetts, United States · On-site
Dermatologist – Danvers, MA (Opening 2027) Optima Dermatology is seeking a Board Certified / Board Eligible General Dermatologist to join our new practice in Danvers, MA. This is an exceptional opportunity to practice al…
Skills: General Dermatology, Patient Care, Clinical Excellence, EMR Proficiency
Salem, Massachusetts, United States · On-site
Dermatologist – Salem, MA (Opening 2027) Optima Dermatology is seeking a Board Certified / Board Eligible General Dermatologist to join our new practice in Salem, MA. This is an exceptional opportunity to practice alongs…
Skills: General Dermatology, Patient Care, Clinical Excellence, EMR Proficiency
Needham, Massachusetts, United States · Hybrid
$162k–$299k/yr
About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trus…
Skills: R&D Strategy, Engineering Leadership, Product Commercialization, Cross-functional Collaboration, Portfolio Management
Lexington, Massachusetts, United States · On-site
$167k–$174k/yr
Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immu…
Skills: In Vitro Pharmacology, In Vivo Pharmacology, Immunology, Biologic Drug Development, Mechanistic Assays
Framingham, Massachusetts, United States · Remote OK
$106k–$197k/yr
About Definitive Healthcare: At Definitive Healthcare (NASDAQ: DH), we’re passionate about turning data, analytics, and expertise into meaningful intelligence that helps our customers achieve success and shape the future…
Skills: SQL, RWD/RWE Analytics, Client Relationship Management, Medical Claim Coding, Data Storytelling
Lexington, Massachusetts, United States · On-site
$279k–$302k/yr
Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immu…
Skills: Translational Medicine, Biomarker Strategy, Clinical Drug Development, Immunology, Clinical Pharmacology
Watertown, Massachusetts, United States · On-site
$24/hr–$30/hr
Join Us in Shaping the Future of Clinical Research Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromisi…
Skills: Clinical Research, Participant Recruitment, Phlebotomy, Vital Signs Collection, Data Entry
Needham, Massachusetts, United States · On-site
$16/hr–$28/hr
Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the ca…
Skills: Specimen Processing, Centrifuging, Aliquotting, Lab Labeling, Medical Terminology
Devens, Massachusetts, United States · On-site
$190k–$210k/yr
Director, Quality Operations and Quality Control Discover Veranova: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitmen…
Skills: Quality Assurance, Quality Control, GMP Compliance, Root Cause Analysis, CAPA
Marlborough, Massachusetts, United States · On-site
IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 25 location…
Skills: Laser System Repair, Electrical Troubleshooting, Mechanical Aptitude, Optical Component Maintenance, ERP Systems
Hyannis, Massachusetts, United States · On-site
$254k–$270k/yr
About Us One Medical is a primary care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable. But this isn’t your average doctor’s office. We’re on a mission to tra…
Skills: Primary Care, Geriatric Care, Patient Engagement, Behavior Change, Electronic Health Records
Marlborough, Massachusetts, United States · On-site
IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 30 location…
Skills: Optical alignment, Laser development, Optical metrology, Python, MATLAB
Waltham, Massachusetts, United States · Hybrid
$195k–$230k/yr
Who We Are: Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib,…
Skills: Patient Marketing, Omnichannel Strategy, Digital Marketing, Rare Disease Expertise, Oncology Marketing
Falmouth, Massachusetts, United States · On-site
The optometrist will conduct eye exams for Acuity Eyecare group and strive to practice to the full capacity of their license. The optometrist will support practice growth by establishing patient relationships and educati…
Skills: Eye Examinations, Patient Education, Ocular History Analysis, Disease Diagnosis, Prescribing Eyeglasses
Watertown, Massachusetts, United States · On-site
$160k–$240k/yr
Who we are: Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically im…
Skills: Strategic Sourcing, Supplier Relationship Management, Contract Negotiation, Procurement, Vendor Diligence
Bedford, Massachusetts, United States · Remote OK
$238k–$322k/yr
About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augment…
Skills: Government Payer Account Management, Medicaid Strategy, Market Access, Reimbursement Management, J Code Management
Bedford, Massachusetts, United States · Remote OK
$238k–$322k/yr
About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augment…
Skills: Payer Account Management, Market Access Strategy, Rare Disease Product Launch, Buy-and-Bill Reimbursement, J Code Management
Bedford, Massachusetts, United States · Remote OK
$238k–$322k/yr
About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augment…
Skills: Payer Account Management, Market Access Strategy, Rare Disease Product Launch, Buy-and-Bill Reimbursement, Managed Care Economics
Bedford, Massachusetts, United States · Remote OK
$238k–$322k/yr
About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augment…
Skills: Payer Account Management, Market Access Strategy, Rare Disease Launch, Buy-and-Bill Reimbursement, J Code Management
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Ensures all GMP-regulated activities, including manufacturing and distribution, comply with global regulatory requirements and company procedures. Responsibilities include auditing CDMOs, conducting batch release, and integrating AI technologies to improve quality assurance efficiency.
Requires a bachelor's degree in a scientific discipline and at least 10 years of experience in pharmaceutical GMP Quality Assurance, specifically with biologics. Candidates must have deep knowledge of FDA, EMA, and ICH regulations and experience with CMO oversight.
Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others.
You can read more at the following links:
At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.
The Associate Director, GMP Quality Assurance is responsible for ensuring that all GMP-regulated activities, including manufacturing, testing, packaging, labeling, storage, and distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports CMC development activities, audits CDMOs, conducts batch release, and performs investigations. The ideal candidate is a hands-on quality leader with strong communication skills and the ability to pivot in a dynamic environment. Additionally, the role explores opportunities to integrate artificial intelligence (AI) technologies to improve efficiency, compliance, and overall quality assurance practices.
Total Compensation Range: $161,500 - $202,000
Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply!
Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate.
Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.
Bringing new treatments to patients faster and more efficiently.
Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. The company has built proprietary technology platforms to optimize critical aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. Formation Bio acquires clinical-stage drugs from pharmaceutical and biotech companies with the goal to develop assets faster, unlock greater value per program and ultimately accelerate access to new treatments for patients. 2025 CNBC Disruptor 50 2025 Fierce 15 Award 2024 Endpoints 11 Award
Offices: 16 E 34th Street, Fl 10, New York, NY 10016, US · Boston, Massachusetts , US
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