Associate Director, Drug Product Development
About The Position
The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.
Requirements
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
- A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
- Demonstrated success in the field of formulations and dosage form development.
- Experience authoring technical reports and CMC sections for regulatory filings.
- Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
- Extensive knowledge of cGMPs.
- Skilled at managing CSPs.
- Demonstrated verbal and written communication skills.
- Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
- Flexibility to travel domestically and internationally.
Responsibilities
- Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
- Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline. Initiate and manage supplier contract agreements as necessary.
- Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs. Serves as person-in-the plant at the CSP sites.
- Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
- Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
- Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
- Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
- Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
- Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
- Other responsibilities as assigned.
Benefits
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
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What This Job Offers
Job Type
Full-time
Career Level
Director
