Senior Manager Analytical Development & QC

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.

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.

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.
• 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. 

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. Please only apply if you reside in these locations or are willing to relocate.

Compensation Range: $177000 - $235000

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.

What We Do

Formation Bio is a tech-driven pharma company differentiated by radically more efficient drug development. Formation Bio has built a technology platform that optimizes all aspects of drug development enabling more efficient trial design faster trial completion and higher quality trial data capture. Formation Bio acquires clinical-stage drugs from pharma and biotech and develops them faster and more efficiently unlocking greater value per program and accelerating access to new treatments for patients. Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology dermatology CNS and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development speeding up the delivery of new treatments. Here every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

Why Work With Us

Our mission is our roadmap and north star. We are an impact-driven culture that hires for intelligence and low egos. We believe that the best employees are both smart and ambitious but also demonstrate humility and curiosity.

Gallery