Formation Bio
Associate Director, GMP Quality
Boston, MA; New York, NY · Director
Sponsorship not specified$162k-$202kDetected 7 days ago
SparkGMPFDA RegulatoryResearchCommunicationCollaboration
About the role
- About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
- 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.
Responsibilities
- Review and approve GMP documents, including SOPs, master batch records, specifications, protocols, and reports
- Perform QA review of executed batch records, supporting manufacturing documents, and testing results to support timely and compliant batch disposition
- Support investigations into deviations, OOS/OOT results, environmental monitoring excursions, and quality events
- Review and maintain Quality Agreements, ensuring external partners meet GMP expectations
- Support preparation for and participation in regulatory inspections and due diligence audits
- Ability to lead investigations and write clear, concise supporting documents
- 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.
Requirements
- Bachelor's degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences)
- Minimum of 10 years' experience in pharmaceutical GMP Quality Assurance, with specific experience in biologics / large-molecule manufacturing and testing
- Experience with CMO oversight or virtual manufacturing models
- The ideal candidate is a hands-on quality leader with strong communication skills and the ability to pivot in a dynamic environment.
Compensation
- Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience.
- In addition to base salary, we offer equity, comprehensive benefits, and generous perks.
- $161,500 - $202,000
Benefits
- Our Vision for AI in Pharma
Company info
- 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.
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.
- Equal Opportunity Formation Bio is committed to building a diverse and inclusive team.
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