Director, Analytical Development and QC - Biologics

We are seeking a highly motivated and detail-oriented Analytical Development and Quality Control biologics expert to join our CMC team. The ideal candidate will play a key role in providing technical leadership for the development, optimization, and validation of drug substance and drug product analytical methods to support the development and manufacturing of large molecules including but not limited to proteins, monoclonal antibodies, and vaccines. The candidate will also provide analytical development oversight of pre-clinical and clinical-stage large molecule asset acquisitions and lead analytical activities at contract development and manufacturing organizations (CDMOs) in close collaboration with Quality and Regulatory colleagues.

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.
• Analytical testing: 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).
• Technology transfer: 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.
• Troubleshooting and problem solving: Investigate and troubleshoot technical issues and ensure timely resolution.
• Collaboration: 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.
• Documentation: Author, review and approve analytical technical documents and standard operating procedures (SOPs) in collaboration with Quality colleagues to assure compliance with current GxP regulations.
• Regulatory submissions: Author, review and strategically contribute to regulatory submissions, including INDs, BLAs, and other regulatory dossiers.
• Innovation and continuous improvement: Stay current with emerging industry trends and technologies and apply advancements to improve analytical testing efficiency and data quality.

About You:

• 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.
• 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.

Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area. Please only apply if you reside in these locations or are willing to relocate.

The target salary range for this role is: $238,000 - $300,000. Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.