Title: Associate Director, Process Chemistry

Location: Waltham, MA

About the Company

Entasis Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including SUL-DUR (targeting A. baumannii infections) being evaluated in Phase 3 clinical trials, zoliflodacin (targeting Neisseria gonorrhoeae) being evaluated in Phase 3 clinical trials, and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections).


Position Summary

We are seeking a pharmaceutical chemical process development professional to develop cost effective, safe, robust, and compliant chemical manufacturing processes to enable the preparation of high-quality drug substance for evaluation in early to late stage clinical development and ultimate commercial supply.


Primary Responsibilities

  • Working in a cross-functional environment to identify drug substance requirements while managing and optimizing project timelines
  • Oversee the development and tech transfer of effective manufacturing processes to GMP manufacture
  • Effectively collaborate with and manage development and manufacturing partners
  • Author and review module 3 sections for global regulatory filings including INDs, IMPDs, and NDAs
  • Ensure that all development and manufacturing activities are conducted in a manner consistent with regulatory requirements while integrating quality by design and quality risk management principles in the API process
  • Work closely within the Pharmaceutical Sciences and Manufacturing teams to contribute to overall product development
  • Ensure compliance of GMP manufactured APIs through partnership with Entasis Quality organization


Knowledge and Skills Required

The idea candidate will have the following qualifications:

  • MS or PhD in organic chemistry with 10-15 years of experience in pharmaceutical chemical process development, with experience from pre-clinical through Phase 3 and NDA
  • Experience working with external development and manufacturing partners
  • Extensive knowledge of fundamental process chemistry concepts, including, but not limited to: organic chemistry, reaction mechanisms, kinetics, thermodynamics, fluid mixing, heat transfer, and Quality by Design
  • Excellent understanding of FDA, EMA and ICH guidance documents and the ability to apply sound regulatory strategies to process chemistry problems
  • Experience inventing, troubleshooting and optimizing organic chemistry processes from mg to multi-kilogram scale
  • Knowledgeable about available analytical techniques required for raw material, in-process and release of pharmaceutical APIs
  • Solid knowledge of quality assurance regulations
  • Experienced in the identification and control of impurities in a manner consistent with existing regulatory guidance
  • Experience reviewing, correcting and approving GMP manufacturing batch records
  • Experience working with multi-functional teams including, but not limited to:  formulation development, analytical development, material management, non-clinical, clinical, and regulatory personnel
  • Excellent written, oral and document control skills
  • Experience auditing potential GMP drug substance manufacturer
  • Experience in technical writing, including but not limited to, process development reports and characterization reports
  • Experience with regulatory authoring including INDs, IMPDs, FDA briefing documents; and NDA
  • Experience with drug substance validation and design of experiments

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