Formation Bio

Formation Bio

Associate Director, Bioanalytical Development

Boston, MA; New York, NY · Director

Sponsorship not specified$178k-$232kDetected 22 days ago
GCPSparkData ScienceLogisticsPharmacologyFDA RegulatoryResearchExperimental DesignMass SpectrometryAnimal StudiesBiostatisticsRegulatory Affairs

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.
  • Your offer will reflect where you fall within the range based on these considerations.

Responsibilities

  • Lead bioanalytical strategy and delivery for assigned programs across small molecules and biologics, aligned to clinical questions and decision points
  • Manage bioanalytical CROs and specialty labs for assigned workstreams: contribute to partner selection, define scopes, set timelines, and monitor performance, quality, and budget
  • Oversee end-to-end bioanalytical execution: protocols, validation reports, sample analysis, data review, and final reports to support program decisions and filings
  • Own day-to-day BA operating processes for assigned programs: assay lifecycle tracking, method transfer planning, issue triage, deviation management, and CAPA follow-up with vendors
  • Partner with Clinical Pharmacology and Clinical Development on study design inputs, sampling strategies, analyte panels, and interpretation of exposure and immunogenicity implications
  • Collaborate with Regulatory Affairs by drafting/reviewing submission components and providing technical input to support IND/CTA and NDA/BLA/MAA activities
  • Align with DMPK/Nonclinical on bioanalytical approaches across studies and support translational PK needs
  • Support diligence and asset evaluation by reviewing bioanalytical packages, identifying gaps/risks, and proposing pragmatic remediation plans
  • Lead bioanalytical strategy and execution for assigned preclinical and clinical programs across small molecules and biologics
  • Lead CRO/vendor execution for assigned workstreams; support partner selection and governance as needed

Requirements

  • PhD in a relevant field with 7+ years of bioanalytical experience in biopharma, including clinical-stage support, or a relevant undergraduate degree with 10+ years of experience
  • Deep LC-MS/MS expertise for PK/TK, troubleshooting, and ISR
  • Strong working knowledge of bioanalytical regulatory expectations and submission-quality documentation

Nice to have

  • Familiarity with GCP/GCLP expectations and audit/inspection readiness for clinical bioanalysis
  • Experience shaping sample logistics (kits, stability, chain of custody) and data flow into filings
  • Preferred: Familiarity with GCP/GCLP expectations and audit/inspection readiness for clinical bioanalysis
  • Preferred: Experience shaping sample logistics (kits, stability, chain of custody) and data flow into filings

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.
Apply directly at Formation Bio →Create a free account for alerts like thisView Formation Bio immigration profile

This listing is sourced directly from Formation Bio's careers page and normalized into a canonical job model.