Associate Director, Analytical Development & QC

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 industry can progress because of the high cost and time of clinical trials. , 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: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology Platform 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. About the Position We are seeking a highly motivated, self-driven and detail-oriented Associate Director of Analytical Development and Quality Control to join our CMC team. This role will provide broad exposure across Formation Bio’s portfolio, requiring the ability to flex between small molecule and biologics programs at different phases of development in an outsourced development model, requiring strong technical skillset, vendor management, and the ability to balance scientific rigor with program timelines.

You will play a key role in providing technical leadership as a subject matter expert for the development, optimization, and validation of drug substance and drug product analytical methods to support outsourced development and manufacturing of small molecule and biologics programs including but not limited to proteins, monoclonal antibodies, and vaccines. In this role you will also oversee all Formation Bio stability programs and closely collaborate with CMC, QA, and Regulatory teams.

Responsibilities

In close collaboration with CDMOs and contract testing laboratories, lead development, optimization and validation of phase-appropriate analytical methods for small molecule and biologics drug substances and drug products. Manage testing (in-process, release, stability) at CDMOs and contract testing laboratories. Provide technical oversight for method transfers, comparability assessments, and laboratory readiness.

Lead selection, qualification, and ongoing performance management of external analytical vendors. Oversee and manage Formation Bio’s stability studies across all programs, including review and approval of stability protocols and review and trending of stability data to support shelf-life and retest dating. Track and publish stability program metrics.

Act as the primary contact for stability-related inquiries. Oversee and manage Formation Bio’s critical reagents and reference standards inventory and testing. Lead investigations of release and stability OOS and OOT results, deviations, CAPAs and change controls.

Author and review analytical sections of CMC documents, including protocols, reports, and regulatory submissions. Author and review of SOPs and work instructions. Closely collaborate with CMC, QA, and Regulatory teams.

About You Analytical Chemistry, Biochemistry, Molecular Biology, or a related discipline Master’s degree with 5+ years or Bachelor’s Degree with 8+ years of relevant small molecule and biologics analytical development and QC experience.