Associate Director, Drug Substance, Biologics

MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.

6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug substance manufacturing (either cell culture or downstream purification)

Demonstrated track record of successfully managing drug substance manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.

Technical expertise in either cell culture or downstream purification for process development, manufacturing, process characterization and process validation for biologics.

Extensive experience working with CDMOs, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.

Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas. These positions will follow a hybrid work model with 1-3 days required at the office.  Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered.

$185,000 - $235,000

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.

The Associate Director, Drug Substance, Biologics, will provide technical, strategic and hands-on operational leadership for all CMC activities related to drug substance development and manufacturing, with a primary focus on Biologics at all stages of development (IND-enabling to commercialization).

The Associate Director, Drug Substance, will be responsible for overseeing the process development, manufacturing and release of drug substances at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug substance manufacturing (either cell culture or downstream purification), strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.

Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.

Partner closely with Drug Product Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Program Management leads to ensure seamless integration of manufacturing activities into overall program execution.

Collaborate with procurement to ensure timely contracting for drug substance manufacturing.

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, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

You can read more at the following links:

Our Vision for AI in Pharma

Our Current Drug Portfolio

Our Technology & Platform