Senior Manager, Analytical Development & QC

Formation Bio•Boston, MA

16h•Hybrid

About The Position

We are seeking a highly motivated, self-driven and detail-oriented Sr. Manager/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.

Requirements

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.
Proven ability to operate effectively in a fast-paced, virtual, and outsourced development environment.
Highly organized with a track record of managing multiple priorities across programs in an outsourced development model.
Strong scientific judgment with the ability to independently assess data quality, identify risks, and recommend mitigation strategies.
Ability to communicate complex analytical concepts clearly to both technical and non-technical stakeholders.
Collaborative mindset with a strong sense of ownership and accountability.
Extensive hands-on experience developing, optimizing, and validating analytical methods for release and stability testing of small molecules and biologics.
Hands-on experience with analytical methods pertinent to bilogics (qPCR, IEF, UHPLC, MS, CE, SDS-PAGE, ELISA, peptide mapping, glycan analysis, etc.) and small molecules (UHPLC, IC, GC, IR, UV, KF, PSD, dissolution, etc.).
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, and SOPs.
Experience with designing stability studies and performing stability data trending according to applicable guidances.
Strong working knowledge of Smartsheet and JMP.
Thorough understanding of ICH, FDA, EMA guidances and GMP requirements governing process development, manufacturing, and stability.
Ability to travel domestically and internationally up to 25% of the time.

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.
Support 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.