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Associate Director, GMP Quality

Formation Bio · Boston, MA; New York, NY · On-site

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About Formation Bio

Building the pharma company of the future. Backed by Sequoia, a16z and Felicis.

About the role

Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate .

What they're looking for

  • Bachelor’s degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences)
  • Minimum of 10 years’ experience in pharmaceutical GMP Quality Assurance, with specific experience in biologics / large-molecule manufacturing and testing
  • Deep understanding of GMP expectations (e.g., FDA, EMA, and ICH) and a commitment to patient safety
  • Excellent communication, organization, and collaboration skills
  • Ensures accuracy and completeness in documentation and decision-making
  • Ability to lead investigations and write clear, concise supporting documents
More about this role

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.

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. 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. 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.

  • 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...

Read the full posting on Formation Bio's site ↗

Quality Assurance

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