Associate Director, Chemical Development
Acadia Pharmaceuticals
June 26, 2026
Remote friendly (Princeton, NJ)
United States
Other
Position Summary:
Responsible for chemical process development, implementation, and management of robust, cost-effective, and safe processes for the manufacture of APIs from research through clinical development and marketing approval. Provides technical development, support, and innovative solutions for drug substances using an external provider network, including technical oversight for externalized drug substance development.
Primary Responsibilities:
- Lead scientific strategy for drug substance development; ensure scalable, efficient, compliant processes meeting clinical/commercial needs.
- Oversee contract service providers (CSPs) to develop, optimize, and scale manufacturing processes (preclinical through commercialization).
- Apply risk assessments and Quality by Design (QbD) to define design space and robust control strategies.
- Develop end-to-end drug substance strategies for product quality, global regulatory approvals, and supply chain flexibility.
- Manage technology transfer, outsourcing, and external manufacturing for reliable, scalable supply.
- Establish/evaluate/manage CSP partnerships (negotiation, performance oversight, issue resolution).
- Ensure cGMP compliance; oversee deviations/change management; partner with Quality/Regulatory for filing impact.
- Lead planning/execution of timelines, deliverables, and CMC documentation for submissions/inspections.
- Provide cross-functional technical leadership and support internal/investigation/diligence activities.
Qualifications:
- Ph.D. in Synthetic Organic Chemistry or related discipline.
- 8–9+ years progressive API development/manufacturing experience; at least 8 years in a scientific role (or equivalent education/experience).
- Leadership managing projects with global contract CDMOs.
- Experience with development-stage small-molecule upstream/downstream process development and control strategies.
- Knowledge of FDA/ICH guidelines for small-molecule drug substance registration, quality, and compliance.
- Strong organic synthetic chemistry and cross-functional API development understanding (pre-IND through NDA).
- CMC expertise for regulatory filings (IND to NDA) and strong cGMP knowledge.
- Excellent communication/presentation; ability to collaborate and direct internal/external teams.
- Negotiation, influence, problem-solving, and conflict resolution skills.
Benefits (as stated):
- Discretionary bonus and equity awards; competitive base salary.
- Medical/dental/vision; employer-paid life, disability, business travel, EAP.
- 401(k) 1:1 match up to 5%; Employee Stock Purchase Plan with 2-year lock-in.
- 15+ vacation days; 13–15 paid holidays.
- 10 days paid sick time; paid parental leave; tuition assistance.
Responsible for chemical process development, implementation, and management of robust, cost-effective, and safe processes for the manufacture of APIs from research through clinical development and marketing approval. Provides technical development, support, and innovative solutions for drug substances using an external provider network, including technical oversight for externalized drug substance development.
Primary Responsibilities:
- Lead scientific strategy for drug substance development; ensure scalable, efficient, compliant processes meeting clinical/commercial needs.
- Oversee contract service providers (CSPs) to develop, optimize, and scale manufacturing processes (preclinical through commercialization).
- Apply risk assessments and Quality by Design (QbD) to define design space and robust control strategies.
- Develop end-to-end drug substance strategies for product quality, global regulatory approvals, and supply chain flexibility.
- Manage technology transfer, outsourcing, and external manufacturing for reliable, scalable supply.
- Establish/evaluate/manage CSP partnerships (negotiation, performance oversight, issue resolution).
- Ensure cGMP compliance; oversee deviations/change management; partner with Quality/Regulatory for filing impact.
- Lead planning/execution of timelines, deliverables, and CMC documentation for submissions/inspections.
- Provide cross-functional technical leadership and support internal/investigation/diligence activities.
Qualifications:
- Ph.D. in Synthetic Organic Chemistry or related discipline.
- 8–9+ years progressive API development/manufacturing experience; at least 8 years in a scientific role (or equivalent education/experience).
- Leadership managing projects with global contract CDMOs.
- Experience with development-stage small-molecule upstream/downstream process development and control strategies.
- Knowledge of FDA/ICH guidelines for small-molecule drug substance registration, quality, and compliance.
- Strong organic synthetic chemistry and cross-functional API development understanding (pre-IND through NDA).
- CMC expertise for regulatory filings (IND to NDA) and strong cGMP knowledge.
- Excellent communication/presentation; ability to collaborate and direct internal/external teams.
- Negotiation, influence, problem-solving, and conflict resolution skills.
Benefits (as stated):
- Discretionary bonus and equity awards; competitive base salary.
- Medical/dental/vision; employer-paid life, disability, business travel, EAP.
- 401(k) 1:1 match up to 5%; Employee Stock Purchase Plan with 2-year lock-in.
- 15+ vacation days; 13–15 paid holidays.
- 10 days paid sick time; paid parental leave; tuition assistance.