Associate Director, Formulation and Drug Product Development

Primary Responsibilities Include

• Act as the subject matter expert for drug product development within the Technical Development group, including formulation development, selection of container closure systems, and sterile fill finish clinical manufacturing.
• Act as main point of contact for CDMO(s) for external formulation development activities, and liaise with the Research group to define, streamline and execute early-stage formulation development efforts.
• Build and enhance internal capabilities for formulation development in the laboratory.
• Responsible for development, tech transfer, and scale-up of drug product processes, and cGMP manufacturing of clinical grade drug product (Phase 1-3).
• Key contributor to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada).
• Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure continuity of drug supply for early clinical evaluation.
• Responsible for driving execution of the formulation development plan at CDMO (PO through delivery).
• Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration.

Education and Skills Requirements

• PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience.
• Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
• Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities.
• Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing.
• Strong experience and knowledge of cGMP manufacturing requirements.
• Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
• Experience managing complex schedules and priorities in a dynamic biotech environment.
• Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs).
• Collaborative work style to be part of a team to identify process gaps and constructively develop solutions.
• Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships.
• Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors.