Formation Bio

Formation Bio

Associate Director, Bioanalytical Development

Boston, MA; New York, NY · Director

Sponsorship not specified$178k-$232kDetected 2 days ago
GCPSparkData ScienceLogisticsPharmacologyFDA RegulatoryResearchExperimental DesignMass SpectrometryAnimal StudiesCommunicationBiostatisticsRegulatory Affairs

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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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

  • 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.
  • We are an equal opportunity employer and welcome candidates from all backgrounds.
  • Our Technology & Platform

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.
  • We've seen a rise in recruiting impersonation scams across the industry, where fake profiles pose as recruiters aiming to trick candidates into sharing personal and financial information through illegitimate interviews and job offers. All legitimate recruiting communications from Formation Bio will come from a @formation.bio email address. If you receive outreach from someone claiming to work at Formation Bio through any other domain or channel, please disregard it and do not share any personal information.
  • Formation Bio is committed to building a diverse and inclusive team.
  • 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.
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