Careers

Title: Associate Director, Formulation 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:

Entasis Therapeutics is seeking a motivated, energetic Associate Director of Formulation Development to join its CMC team. The successful candidate will be responsible for leading the formulation development and drug product manufacturing of our small molecule pipeline products across preclinical and clinical development, as well as contributing to the commercialization of Phase 3 programs.  The incumbent will lead and oversee planning and execution of formulation development, tech transfer, and manufacturing with external development and manufacturing partners. The position requires enthusiasm, passion, and attention to detail and this position may require some travel to assist in tech transfer and manufacturing-related activities across the GMP manufacturing sites.

 

Primary Responsibilities:

  • The successful candidate will design and develop appropriate oral and/or IV formulations for early to late stage clinical development programs.
  • Contribute to the validation and commercialization of current late stage drug product manufacturing processes.
  • Contribute to the selection of appropriate drug product development and manufacturing partners
  • Manages formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities.
  • Serve as the scientific leader in formulation, develop strategic formulation development plans in alignment with our clinical trial plans and company goals. Design phase appropriate formulations at different stage of development (preclinical to clinical phase III)
  • Manage project assignment and work distribution for formulation team
  • Designs and executes pre-clinical and clinical formulation development experiments to develop and support solid and liquid oral dosage form products.
  • Conducts physicochemical characterization of different drug substance lots as needed.
  • Work in close collaboration with the Project and CMC teams and related functions, including discovery, non-clinical development, process development, analytical development, Quality and Regulatory.
  • Site selection of CDMO’s for drug product development and manufacturing.
  • Manages formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities.
  • Authors and reviews formulation related sections for regulatory filings, development reports and other development related documents.
  • Actively communicates, collaborates with and contributes to other functional areas to solve problems and achieve goals.
  • Oversee tech transfer and future validation of drug product manufacturing processes.
  • Oversee and manage CDMOs including authoring and reviewing of Batch Records/Master Production Records and specifications.
  • Keep current with developments in product development and make recommendations for implementation of new systems/technologies.
  • Execute IND-enabling characterization studies and routine characterization studies in support of regulatory commitments.
  • Support process development and process understanding through QbD principles.
  • Support investigation of OOS and OOT test results, and follow-up of corrective actions.
  • CQA assessments and risk assessments.

Candidate requirements:

  • 7+ years of experience in pharmaceutical sciences/formulation development field, working on projects from pre-clinical to Phase 3/NDA phase.
  • Experienced in the oversight of formulation development activities with external CDMOs in a virtual environment.
  • Extensive knowledge of fundamental formulation processes and controls for IV and oral dosage forms.
  • Knowledge of sterility controls for the successful production of sterile drug product formulations.
  • Knowledge of encapsulation and tablet methodologies for oral drug product formulations.
  • Knowledge of extended release solid oral dosage forms.
  • Knowledge of combination drug product formulations a plus.
  • Excellent understanding of FDA, EMA and ICH guidance documents and the ability to apply sound regulatory strategies to formulation chemistry problems.
  • Experience inventing, troubleshooting and optimizing formulation processes from small to commercial scales for IV and parenteral formulations.
  • Minimum of 5 years of experience working in a GMP environment with solid knowledge of quality assurance regulations.
  • Knowledgeable about the analytical techniques required for excipient, in-process and release of pharmaceutical compounds (both IV and oral)
  • Experienced in the identification and control of impurities in a manner consistent with existing regulatory guidance.
  • Experience with Quality by Design, DOE, and drug product validation.
  • Experience reviewing, correcting and approving GMP documentation, including batch records, OOS, OOT investigations and deviations.
  • Experience working with multi-functional teams including, but not limited to formulation development, analytical development, material management, non-clinical, and clinical personnel.
  • Excellent written, oral and document control skills.
  • Experience auditing potential GMP drug product manufacturers.
  • Experience in technical writing, including but not limited to, formulations development reports and characterization reports.
  • Experience authoring drug product sections of INDs, IMPDs, NDA and FDA briefing documents.

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