Job Description: Director/Senior Director, Drug Product Development
This individual will serve as an integral team member with exposure to multiple facets of business operations. The Director/Senior Director, Drug Product Development will lead drug product formulation and filling process development as well as cGMP manufacturing at Client company’s CDMOs. Additional features of the position include responsibility to lead process scale up and characterization studies required to support drug product and formulation development life-cycle management.
Client company is a growing organization based out of the Seaport area of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States.
This position allows for hybrid work with ~2-3 days/week requiring onsite attendance.
Major Duties/Responsibilities
• Lead drug product formulation and formulation process development, as well as cGMP manufacturing at CDMOs.
• Lead process scale up and characterization studies required to support drug product and formulation development life-cycle management.
• Perform risk assessments/FMEAs through process development to process validation.
• Lead internal and external formulation development for injectable drug products and ultimate technical transfer(s), as applicable, of the manufacturing process to commercial manufacturing site(s).
• Partner with key stakeholders and work collaboratively with cross-functional CMC, quality, regulatory, project management, legal, supply chain, and other functions to meet company goals.
• Author applicable drug product sections in regulatory submission documents and support global filings.
• Author technical reports and applicable sections of clinical pharmacy manual(s).
• Establish applicable technical procedures and business process flows to support drug product life-cycle management.
Education & Professional Experience Required:
• Ph.D. in Pharmaceutical Sciences or relevant technical field with 8+ years of relevant work experience, or M.S. (or equivalent degree) with 12+ years of relevant work experience.
• Minimum of 5 years of experience managing cGMP outsourced development and manufacturing operations.
• Hands-on experience in formulation development and aseptic drug product manufacturing.
• A proven track record in developing and scaling up formulations from pre-IND through late-stage development for peptides, oligonucleotides, and conjugate-based products.
• Strong knowledge of analytical techniques required for formulation process development and characterization of injectable drug products. Familiarity with analytical method development is a plus.
• Exceptional problem-solving and decision-making skills, with the ability to integrate complex scientific information into drug development plans.
• Detail-oriented with an eye for anticipating and mitigating risks and issues.
• Sound knowledge of pharmaceutical and engineering principles in liquid dosage formulation development for both clinical and commercial scales.
• Excellent project management and communication skills.
• Must thrive in a fast-paced innovative start-up environment.
• Strong working knowledge of FDA, EU, and ICH guidelines and regulations, and familiarity with phase[1]appropriate cGMP requirements.
• Experience with successful CMC regulatory submissions (IND, BLA, IMPD, MAA, etc.).
Working Conditions: Busy office/laboratory environment with frequent deadlines and interruptions
Travel: Travel is minimal (10-20%)
Physical Requirements: Subject to periods of sitting or standing, vision is required to monitor data.