Formation Bio

Formation Bio

Associate Director, Analytical Development & QC

Boston, MA; New York, NY · Director

Sponsorship not specified$178k-$232kDetected 22 days ago
SparkVendor ManagementPerformance ManagementGMPFDA RegulatoryqPCRMolecular BiologyResearchProtein AnalysisLeadershipCollaborationOrganizational Skills

About the role

  • About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
  • 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.
  • Track and publish stability program metrics.

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.
  • 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.
  • 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.
  • Closely collaborate with CMC, QA, and Regulatory teams.
  • Extensive hands-on experience developing, optimizing, and validating analytical methods for release and stability testing of small molecules and biologics.
  • 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.

Requirements

  • 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.
  • Experience with designing stability studies and performing stability data trending according to applicable guidances.
  • Strong working knowledge of Smartsheet and JMP.
  • Ability to travel domestically and internationally up to 25% of the time.

Compensation

  • Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience.
  • In addition to base salary, we offer equity, comprehensive benefits, and generous perks.
  • $177,500 - $232,000

Benefits

  • Our Vision for AI in Pharma

Company info

  • 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.

Equal opportunity

  • Formation Bio is committed to building a diverse and inclusive team.
  • We are an equal opportunity employer and welcome candidates from all backgrounds.
  • All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.
  • Equal Opportunity Formation Bio is committed to building a diverse and inclusive team.
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This listing is sourced directly from Formation Bio's careers page and normalized into a canonical job model.