Associate Director, Early Stage Drug Product Development

Seeking talent near: Princeton NJ ; San Diego CA

Position Summary

The Associate Director in the Early Stage Drug Product Development organization at Acadia is responsible for the development of pharmaceutical formulations primarily intended for early-stage clinical trials and preclinical animal studies. This role also supports drug discovery teams by assisting in the selection of optimal drug candidates through detailed physicochemical characterization and assessment of compound properties. The incumbent will focus on formulation strategies tailored to early development phases ensuring that candidates are suitably prepared for initial safety and efficacy evaluations. Additionally collaboration with research scientists and external partners is essential to address technical challenges and advance promising compounds toward clinical readiness.

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 The role will be critical in ensuring that we select developable drug candidates reduce risk and accelerate the introduction of new chemical entities into the Acadia pipeline.

Primary Responsibilities

• Designs and develops pharmaceutical formulations to support early stage clinical trials providing acceleration options such as on-site compounding and impromptu type of drug products.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development oversee operations at existing suppliers. Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development 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.
• With Translational Sciences teams plans conduct of preclinical and toxicological studies and develops requisite formulations for the same considering developability of the new drug candidates.
• Develops phase appropriate formulations for new drug candidates in FIH Phase 1 and POC studies employing resource sparing approaches such as compounded formulations and/or on-site preparations.
• Conduct physicochemical characterizations of the new drug candidates to support developability assessments.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs BPRs development reports and relevant documents prepared by CSPs.
• Liaises with the CMC team late-stage formulation team and formulation development management to establish the development strategy for formulation of the new drug candidates.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Collaborates with regulatory teams in preparation of the health authority submissions for the early clinical trial applications (e.g. IND CTA IMPD)
• Other responsibilities as assigned.

Education/Experience/Skills

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.

Must possess:

• Comprehensive understanding of the physicochemical characterization of new drug candidates to assess developability formulations for early stage clinical studies and dosage form formulation and package development.
• 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.

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 to domestic and international locations is required.

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