Associate Director, Drug Product Development
Acadia Pharmaceuticals
5 months ago
On-site
Princeton, NJ
Operations
Position Summary
The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s drug candidates across all development stages. Provides technical oversight, expertise, and guidance for externalized drug product development activities. Manages formulation, packaging, and process development for oral solid, liquid, and injectable dosage forms, from clinical development through process validation and life cycle management. Manages related activities at Contract Service Providers (CSPs) and contributes to resolution of complex technological issues and implementation of new manufacturing process technology for clinical and commercial distribution.
Primary Responsibilities
- Design and develop pharmaceutical formulations and manufacturing processes to support clinical trials, registration, and product launch.
- Evaluate and validate new drug product CSPs to support development, scale-up, and commercialization; initiate and manage supplier contract agreements as needed.
- Coordinate and supervise CSP development and scale-up to manufacturing of clinical formulations and finished dosage forms; serve as person-in-the-plant at CSP sites.
- Plan scientific/technical work; interpret results and evaluate data; develop scientifically based conclusions; write and present technical reports.
- Review clinical supply requirements and plan manufacturing schedules with CSPs to ensure uninterrupted clinical trial supply.
- Perform risk assessments of manufacturing process and product at key milestones; address findings with CSPs.
- Author and review technical reports and regulatory-submission documents (including review of MBRs, BPRs, and development reports prepared by CSPs).
- Liaise with analytical, manufacturing, quality assurance, and regulatory counterparts to develop development and life cycle management plans and protocols.
- Adhere to cGMP/GxP work practices; support Quality Assurance compliance with applicable procedures and requirements; assist CSPs with health authority and pre-approval inspections.
- Other responsibilities as assigned.
Education and Experience
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field (or equivalent combination of education and relevant experience).
- Minimum 10 years of progressively responsible experience in formulation and manufacturing process development; leadership experience desired.
- Demonstrated success in formulation and dosage form development.
- Experience authoring technical reports and CMC sections for regulatory filings.
Must Possess
- Comprehensive understanding of dosage form formulation and package development; manufacturing process development, scale-up, optimization, and validation.
- Extensive knowledge of cGMPs.
- Skilled at managing CSPs.
- Demonstrated verbal and written communication skills.
- Ability to align resources across multiple functional areas to achieve goals.
- Flexibility to travel domestically and internationally.
The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s drug candidates across all development stages. Provides technical oversight, expertise, and guidance for externalized drug product development activities. Manages formulation, packaging, and process development for oral solid, liquid, and injectable dosage forms, from clinical development through process validation and life cycle management. Manages related activities at Contract Service Providers (CSPs) and contributes to resolution of complex technological issues and implementation of new manufacturing process technology for clinical and commercial distribution.
Primary Responsibilities
- Design and develop pharmaceutical formulations and manufacturing processes to support clinical trials, registration, and product launch.
- Evaluate and validate new drug product CSPs to support development, scale-up, and commercialization; initiate and manage supplier contract agreements as needed.
- Coordinate and supervise CSP development and scale-up to manufacturing of clinical formulations and finished dosage forms; serve as person-in-the-plant at CSP sites.
- Plan scientific/technical work; interpret results and evaluate data; develop scientifically based conclusions; write and present technical reports.
- Review clinical supply requirements and plan manufacturing schedules with CSPs to ensure uninterrupted clinical trial supply.
- Perform risk assessments of manufacturing process and product at key milestones; address findings with CSPs.
- Author and review technical reports and regulatory-submission documents (including review of MBRs, BPRs, and development reports prepared by CSPs).
- Liaise with analytical, manufacturing, quality assurance, and regulatory counterparts to develop development and life cycle management plans and protocols.
- Adhere to cGMP/GxP work practices; support Quality Assurance compliance with applicable procedures and requirements; assist CSPs with health authority and pre-approval inspections.
- Other responsibilities as assigned.
Education and Experience
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field (or equivalent combination of education and relevant experience).
- Minimum 10 years of progressively responsible experience in formulation and manufacturing process development; leadership experience desired.
- Demonstrated success in formulation and dosage form development.
- Experience authoring technical reports and CMC sections for regulatory filings.
Must Possess
- Comprehensive understanding of dosage form formulation and package development; manufacturing process development, scale-up, optimization, and validation.
- Extensive knowledge of cGMPs.
- Skilled at managing CSPs.
- Demonstrated verbal and written communication skills.
- Ability to align resources across multiple functional areas to achieve goals.
- Flexibility to travel domestically and internationally.