Title: Director/Sr. Director, Analytical Method Development

Location: Waltham, MA

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 Description:

The Director/Sr. Director will lead analytical development activities for both drug substance and drug product across the Entasis development pipeline.  She/He will lead and implement the necessary analytical strategies to support the preclinical development and clinical development of current small molecule assets, as well as commercialization of two phase 3 programs.  The incumbent will lead and oversee planning and execution of development, tech transfer, testing and validation with external development and manufacturing partners. The position requires enthusiasm, passion, and attention to detail. This position may require up to 20% travel to assist in tech transfer and manufacturing-related activities across the GMP manufacturing sites.


Primary Responsibilities:

  • Lead analytical development activities for early and late stage small molecule pharmaceutical development
  • Lead analytical method development, validation, tech transfer activities in preparation for commercialization of two programs currently in phase three
  • Collaborate with manufacturing / analytical testing partners and oversee analytical development and testing across both drug substance and drug product 
  • Development of Module 3 analytical content in collaboration with Regulatory Affairs, serving as the analytical lead for associated regulatory interactions
  • Development of phase appropriate, risk-based quality systems in collaboration with Quality
  • Author, review, and approve Requests for Proposals (RFPs), technical reports, test procedures, validation protocols and reports
  • Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences
  • Keep current with developments in analytical methodologies and make recommendations for implementation of new methods/equipment
  • Execute IND-enabling characterization studies and routine characterization studies in support of regulatory commitments
  • Support process development and process understanding by ensuring appropriate analytics are executed
  • Lead development activities such as stability studies, comparability studies, establishment of clinical phase-appropriate specifications and control strategies for starting materials, drug substance, excipients and drug product
  • Participate in assessment of GMP method change controls, investigation of OOS and OOT test results, and follow-up of corrective actions
  • Review CMO/CTL SOPs, qualification protocols and validation protocols
  • Participate in Process Validation planning and execution and other NDA/MAA-enabling activities
  • CQA assessments and risk assessments
  • Collaborate effectively with the Project Management, Quality, Manufacturing, and Regulatory groups to meet program goals


Candidate requirements:

  • Advanced degree in analytical chemistry with 10+ years pharmaceutical development experience
  • Pharmaceutical development experience from preclinical through commercialization
  • Strong analytical, problem solving and critical thinking skills
  • Demonstrated experience authoring relevant sections of US and EU regulatory filings including IND, IMPD and NDA
  • Demonstrates clear and succinct verbal and written communication skills
  • Familiar with FDA and EMA guidance documents relevant to small molecule pharmaceutical development
  • Working knowledge of quality systems requirements
  • Experience in cGMP manufacturing and testing
  • Excellent organizational skills with the ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities while maintaining attention to detail
  • Demonstrated leadership skills and the ability to collaborate with and effectively influence others. Prior experience managing functional teams and representing function in CMC teams.

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