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Head of Pharmaceutical Development – Drug Product

Job
Head of Pharmaceutical Development – Drug Product
Location
Woburn, MA
Employment Type
Full Time
Starting
ASAP
Required qualifications
  • Management:  Build, recruit and retain a world class Drug Product Development team.  Direct and manage the day-to-day activities associated with the development of sterile injectable and OSD drug product candidates.
  • Drug Product Formulation Development: Direct formulation development activities and lead the drug product team in the CONTINUUS pharmaceuticals aseptic and OSD drug product laboratories.
  • Drug Product Analytical Methods and Specifications: Collaborate with the Analytical Development team to develop methods and establish phase appropriate specifications for drug products.
  • Drug Product Technology Transfer: Accountable for the development and implementation strategy of the technology transfer of drug product candidates from the lab/pilot plant scale to the commercial manufacturing scale.
  • Drug Product Manufacture: Participate In the design and implementation of the CONTINUUS Pharmaceuticals ICM (Integrated Continuous Manufacturing) Factory with focus on the sterile injectable vial filling operation and OSD production area.
  • Regulatory Support: Author, review and finalize drug product documents for NDA/ANDA submissions, as well as annual reports. Maintain a current knowledge of CMC regulations and guidance.
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    Phone: (781) 281-0115 Main Office

    Email: [email protected]