Director, Analytical Development and QC, Biologics

Summary

Join Formation Bio, a tech and AI-driven pharma company, as an Analytical Development and Quality Control biologics expert. You will provide technical leadership for developing, optimizing, and validating analytical methods for large molecules. Responsibilities include overseeing analytical activities at CDMOs, supporting technology transfer, troubleshooting, collaborating with cross-functional teams, and contributing to regulatory submissions. The ideal candidate possesses a strong background in large molecule analytical development, extensive hands-on experience with various analytical methods, and a thorough understanding of relevant regulations. This role offers a competitive salary, equity, generous perks, hybrid flexibility, and comprehensive benefits. Formation Bio prioritizes hiring in NYC and Boston, with remote options considered for specific locations.

Requirements

• MS or Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology, or a related discipline
• 7+ years of relevant experience in large molecule analytical development
• Experience in overseeing and leading within CMC teams early to late development analytical activities for large molecule therapeutics
• Demonstrated ability to manage analytical activities across multiple programs. Demonstrated ability to oversee, manage and direct work of consultants and external collaborators
• Experience overseeing and leading analytical activities at CDMOs and contract laboratories
• Extensive hands-on experience with analytical methods pertinent to biopharmaceuticals (qPCR, IEF, HPLC, MS, CE, SDS-PAGE, ELISA, peptide mapping, glycan analysis, etc.)
• Extensive hands-on experience developing, optimizing, and validating analytical methods for characterization and stability of large molecules
• Experience with proposing and establishing drug substance and drug product specifications
• Experience with authoring and reviewing technical documents such as test methods, method development reports, validation protocols, validation reports, specification justification reports, retest and shelf-life memos, standard operating procedures and other technical documents following regulatory requirements
• Experience in reviewing release data packages
• Experience with designing stability studies and performing stability data trending according to applicable guidances
• Thorough understanding of ICH, FDA, and EMA guidances and GMP requirements governing process development, manufacturing, and stability
• Experience with authoring regulatory submissions such as INDs, BLAs, etc

Responsibilities

• Provide analytical development technical leadership for pre-clinical and clinical-stage large molecule therapeutics across the Formation Bio portfolio
• Provide analytical development technical oversight for pre-clinical and clinical-stage large molecule asset acquisitions
• Oversee and provide technical leadership for all analytical activities at CDMOs and contract laboratories (routine testing in support of manufacturing, method development, method verifications/qualifications/validations, degradation pathway studies, stability, and others)
• Support the transfer of analytical methods from in-licensed asset laboratories to Formation Bio-selected laboratories and from method development laboratories to QC and manufacturing teams
• Investigate and troubleshoot technical issues and ensure timely resolution
• Collaborate cross functionally with Manufacturing, Quality, and Regulatory colleagues to ensure seamless integration of analytical methods into the production process and timely delivery of products to the clinic. Collaborate with Manufacturing and Quality colleagues on the CDMO selection process. Cultivate strong relationships with CDMOs, contract laboratories, consultants, and acquisition partners
• Author, review and approve analytical technical documents and standard operating procedures (SOPs) in collaboration with Quality colleagues to assure compliance with current GxP regulations
• Author, review and strategically contribute to regulatory submissions, including INDs, BLAs, and other regulatory dossiers
• Stay current with emerging industry trends and technologies and apply advancements to improve analytical testing efficiency and data quality

Preferred Qualifications

• Experience with analytical testing of cell and gene therapies, small molecules, and/or topicals is a plus
• Ability to travel domestically and internationally approximately 25% of the time

Benefits

• Salary ranges are informed in part by geographic location, in addition to other factors. The target salary ranges for this role are: NYC Metro Area, Boston Metro Area, SF Bay Area : $250,000 - $300,000 All Other Eligible Remote Locations : $238,000 - $285,000
• Equity
• Generous perks
• Hybrid flexibility
• Comprehensive benefits