Title: Associate Director/Director, Formulation Development
Location: Waltham, MA
Entasis Therapeutics is seeking a motivated, energetic Associate Director/Director of Formulation Development to join its CMC team. You will be responsible for leading the drug delivery and formulation development of products in the pipeline across discovery through process scale-up.
- Responsible for quality, quantity and timelines for formulation projects and providing subject matter expertise to project teams
- Collaborate closely with analytical/CMC collegues to develop and implement specifications for drug substance and drug products in development
- Communicates with project teams, internal and external stakeholders to ensure understanding of requirements, prioritization and timely delivery of product knowledge, data and documentation
- Prepares key clinical documents for regulatory submissions
- 10-15 years of experience 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 CMOs in a 100% 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 experience working in a GMP environment; 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 guidances.
- 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 with regulatory writing such as INDs, IMPDs, and FDA briefing documents; NDA writing a plus