Director, Formulation Development

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The Director, Formulation 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. This role will provide technical oversight, expertise, and guidance of externalized drug product development related activities at the Contract Service Providers (CSPs). The scope includes the development of formulations, package, and process for all modes of administration, including oral solid, liquid, and injectable dosage forms for drug candidates ranging from early-stage development to validation and life cycle management. You will contribute both internally and externally to resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. This position will ensure optimized development, reduced risk, and accelerated development of new assets for commercialization.

Primary Responsibilities

• Design and develop formulations and manufacturing processes to support clinical trials, registration, and commercial product launches.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support the development, scale-up, and commercialization of the new drug candidates in the Acadia pipeline, including negotiating and managing supplier contract agreements.
• Coordinate and supervise technology transfers and the development, scale-up, and manufacturing of clinical formulations and finished dosage forms at CSPs.
• Ensure appropriate timelines are in place to meet the clinical supply and registration needs to ensure technology transfer, validation, and regulatory outcomes are met in a resource-sparing manner.
• Plan project-related scientific and technical activities, e.g., interpretation of results, evaluation of data, formulating relevant and scientifically based conclusions, and writing and presenting technical reports.
• Perform risk assessments of the manufacturing process and product at key development milestones.
• Author, review, and approve pharmaceutical development reports and other technical documentation required for regulatory submissions, such as IND, CTA, IMPD, NDA, MAA, MBRs, BPRs, development reports, or relevant documents prepared by CSPs or other filings.
• Draft SOPs as needed to support manufacturing of finished drug product and clinical trial materials.
• 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 pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Master’s degree in Pharmaceutical Sciences or a related field. Ph.D. degree is highly preferred.
• Targeting 10 years’ experience with progressively increasing responsibility in pharmaceutical development, 6 years in a leadership role, and experience leading cross-functional teams is preferred.
• Technical focus on oral solid and liquid dosage forms; some experience developing injectable and other dosage forms preferred.
• Must have experience with written technical and/or scientific documents.
• Equivalent combination of relevant education and applicable job experience may be considered.

Key Skills:

• Demonstrated success in formulations and oral dosage form development, with exposure to combination products, including modified release and injectable dosage forms.
• Comprehensive understanding of the dosage formulation development process for new chemical entities, dosage form manufacturing process development, scale-up, optimization, and validation processes.
• Extensive knowledge of cGMPs and experience in the development of NDAs or other marketing authorization applications.
• Expert knowledge of advanced principles, concepts, and theories related to product, primary package, and process development.
• Skilled at managing CSPs (CROs and CMOs).
• Proficient at creating and communicating a clear vision among team members, effectively aligning resources and activities to achieve functional area and division goals.
• Ability to inspire and energize others through expert technical knowledge, personal leadership, influence, and thorough planning and drive for timely and appropriate results.
• Flexibility to travel domestically and internationally.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business matters.

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