Director/Senior Director of Drug Product Development Loc: Charlestown, MA
100,000 - 200,000
Job Description:
Job Description
Our Client is seeking an experienced Director/Senior Director of Drug Product Development to support early stage programs within their development portfolio. This individual will interact with colleagues in CMC (drug substance and analytical), pre-clinical safety and clinical groups to ensure that suitable materials are available for pre-clinical and clinical studies. He will be responsible for both manufacturing and formulation efforts. This position will report to the Senior Vice President for Development.
The position is available as both a long-term contract and full time employment basis.
Key Responsibilities:
• Work with internal and external audiences to meet agreed upon milestones within established time and budget targets
• Identify, manage and contribute to external formulation collaborations
• Interact closely with internal R&D groups (safety, toxicology, clinical) and partners in conducting efficacy and formulation studies
• Contribute to scientific and strategy discussions to advance and enhance product candidates
• Contribute to relevant sections of domestic and international regulatory filings
• Manage pre-clinical safety drug product manufacturing
• Manage clinical drug product manufacturing
Requirements:
• Ph.D. in Chemistry, Chemical Engineering or a related field and at least 5 yearsâ?? industry experience in formulation development and drug product manufacturing. A Masterâ??s degree is acceptable with 10 plus years of industry experience
• Exceptional knowledge of small molecule solid oral dosage form drug product development and formulation-optimization and drug product characterization
• Strong fundamental understanding of physical and bio-pharmaceutical properties and their importance in formulation design
• Working knowledge and know-how to support pre-clinical and clinical studies with variety of formulation approaches and delivery routes
• Experience with technologies for solubility/bioavailability enhancement of poorly soluble drug candidates