Associate Director, Early Stage Drug Product Development
Acadia Pharmaceuticals
8 hours ago
On-site
Princeton, NJ
Clinical Research and Development
Primary Responsibilities:
- Design and develop pharmaceutical formulations to support early-stage clinical trials (including on-site compounding and prepared drug products).
- Evaluate and validate new drug product Contract Service Providers (CSPs); oversee existing suppliers; initiate/manage supplier contracts.
- Coordinate and supervise development of clinical formulations and finished dosage forms at CSPs (serves as person-in-the-plant at CSP sites).
- Plan and execute scientific/technical activities (interpret results, evaluate data, draw conclusions); write and present technical reports.
- With Translational Sciences teams, plan preclinical and toxicology studies and develop required formulations based on developability.
- Develop phase-appropriate formulations for FIH, Phase 1, and POC studies using resource-sparing approaches (compounded and/or on-site preparations).
- Perform physicochemical characterization to support developability assessments.
- Author/review technical reports and documents for regulatory submissions; review CSP-prepared MBRs, BPRs, and development reports.
- Partner with CMC and formulation development teams to establish formulation development strategy.
- Adhere to cGMP/GXP practices; coordinate with Quality Assurance and Regulatory teams for IND/CTA/IMPD submissions.
Education/Experience:
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field (or equivalent education/industry experience).
- Minimum 10 years’ progressively responsible experience in formulation and manufacturing process development (leadership experience desired).
- Demonstrated success in formulations/dosage form development.
- Experience authoring technical reports and CMC sections for regulatory filings.
Must possess:
- Deep understanding of physicochemical characterization and developability assessments.
- Extensive cGMP knowledge.
- Ability to manage CSPs.
- Strong verbal and written communication skills.
- Ability to align resources across functional areas.
- Flexibility to travel domestically and internationally.
Physical Requirements:
- Regular standing/walking/sitting and use of hands; occasional lifting/moving up to 20 pounds; ability to travel domestically and internationally.
Benefits:
- Discretionary bonus and equity awards; medical/dental/vision insurance; employer-paid life/disability/business travel/EAP; 401(k) match (1:1 up to 5%); Employee Stock Purchase Plan; 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance.
- Design and develop pharmaceutical formulations to support early-stage clinical trials (including on-site compounding and prepared drug products).
- Evaluate and validate new drug product Contract Service Providers (CSPs); oversee existing suppliers; initiate/manage supplier contracts.
- Coordinate and supervise development of clinical formulations and finished dosage forms at CSPs (serves as person-in-the-plant at CSP sites).
- Plan and execute scientific/technical activities (interpret results, evaluate data, draw conclusions); write and present technical reports.
- With Translational Sciences teams, plan preclinical and toxicology studies and develop required formulations based on developability.
- Develop phase-appropriate formulations for FIH, Phase 1, and POC studies using resource-sparing approaches (compounded and/or on-site preparations).
- Perform physicochemical characterization to support developability assessments.
- Author/review technical reports and documents for regulatory submissions; review CSP-prepared MBRs, BPRs, and development reports.
- Partner with CMC and formulation development teams to establish formulation development strategy.
- Adhere to cGMP/GXP practices; coordinate with Quality Assurance and Regulatory teams for IND/CTA/IMPD submissions.
Education/Experience:
- Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field (or equivalent education/industry experience).
- Minimum 10 years’ progressively responsible experience in formulation and manufacturing process development (leadership experience desired).
- Demonstrated success in formulations/dosage form development.
- Experience authoring technical reports and CMC sections for regulatory filings.
Must possess:
- Deep understanding of physicochemical characterization and developability assessments.
- Extensive cGMP knowledge.
- Ability to manage CSPs.
- Strong verbal and written communication skills.
- Ability to align resources across functional areas.
- Flexibility to travel domestically and internationally.
Physical Requirements:
- Regular standing/walking/sitting and use of hands; occasional lifting/moving up to 20 pounds; ability to travel domestically and internationally.
Benefits:
- Discretionary bonus and equity awards; medical/dental/vision insurance; employer-paid life/disability/business travel/EAP; 401(k) match (1:1 up to 5%); Employee Stock Purchase Plan; 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance.