Drug Product SME Consultant

Primary Function of Position

The role would serve as the SME and advise on any challenges /issues that arise in formulation development, process optimization, and drug product manufacturing at external CDMOs to support non-clinical and clinical activities. The consultant will ensure scientific and technical standards are robust, data packages support regulatory filings, and quality controls are implemented in partnership with Quality Assurance and Regulatory Affairs.

Responsibilities Expectations

• Develop and execute phase-appropriate strategies for the accelerated development of small molecule drug products, aligning with program goals and regulatory expectations.
• Provide technical leadership to Contract Development and Manufacturing Organizations (CDMOs), ensuring development programs are on track and compliant with regulatory and project & overall program objectives.
• Direct CDMO partners in process development, guiding work according to Quality by Design (QbD) principles, driving specification justification studies, process characterization, and validation to identify critical process parameters (CPPs), establish proven acceptable ranges (PARs), and characterize critical quality attributes (CQAs).
• Collaborate cross-functionally-partnering with Quality Assurance, Regulatory Affairs, and other CMC groups to drive successful drug product development and regulatory readiness.
• As required, author and review regulatory documents, contributing to key sections of Investigational New Drug (IND) and New Drug Application (NDA) submissions related to pharmaceutical development and manufacturing.

Qualifications - Requirements

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or related discipline with a minimum of 10 years' small molecule drug product development experience in the biopharmaceutical industry.
• Proven track record in leading late-stage (Phase 3) drug product programs
• In-depth knowledge of FDA and ICH guidelines pertaining to drug product development and registration.
• Direct experience providing technical oversight and guidance to CDMOs
• Experience authoring regulatory CMC sections for IND/NDA filings.
• Thorough understanding of cGMP requirements, regulatory documentation, and working in a regulated manufacturing environment.