Associate Director, Chemical Development
Acadia Pharmaceuticals
June 26, 2026
Remote friendly (San Diego, CA)
United States
Operations
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. Leads technical development, support, innovative solutions, and commercialization of drug substances using external providers; provides technical oversight and guidance for outsourced drug substance development activities.
Primary Responsibilities:
- Lead scientific strategy for drug substance development to ensure scalable, efficient, compliant processes meeting clinical and commercial needs.
- Oversee contract service providers (CSPs) to develop, optimize, and scale manufacturing from preclinical through commercialization.
- Apply risk assessments and Quality by Design (QbD) to define design space and 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 to build reliable, scalable supply.
- Establish, evaluate, and manage CSP partnerships (contract negotiation, performance oversight, issue resolution).
- Ensure cGMP compliance; oversee deviations and change management; partner with Quality/Regulatory on filing impact.
- Lead CMC timeline/deliverables and documentation for regulatory submissions and inspections.
- Provide cross-functional leadership and technical expertise for internal teams and external diligence.
Education/Experience/Skills:
- Ph.D. in Synthetic Organic Chemistry or related field.
- 8–9+ years API development/manufacturing experience in pharma/biotech; 8+ years in a scientific role (or equivalent education/experience).
- Leadership managing projects with global contract CDMOs.
- Small-molecule development manufacturing experience (upstream/downstream); strong control strategy knowledge.
- FDA and ICH knowledge for small-molecule drug substance.
- Organic synthesis and API development understanding (pre-IND through NDA).
- CMC expertise for regulatory filings (e.g., IND to NDA) and cGMP experience.
- Strong communication/presentation; ability to direct internal/external collaborators.
- Negotiation, influence, problem-solving, conflict resolution, and vision-setting.
Benefits:
- Competitive base; eligible for discretionary bonus and equity awards.
- Medical, dental, vision insurance; employer-paid life/disability/travel/EAP.
- 401(k) with 1:1 match up to 5%; Employee Stock Purchase Plan.
- 15+ vacation days; 13–15 paid holidays; 10 paid sick time.
- Paid parental leave; tuition assistance.
Salary Range:
$154,200—$192,700 USD
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. Leads technical development, support, innovative solutions, and commercialization of drug substances using external providers; provides technical oversight and guidance for outsourced drug substance development activities.
Primary Responsibilities:
- Lead scientific strategy for drug substance development to ensure scalable, efficient, compliant processes meeting clinical and commercial needs.
- Oversee contract service providers (CSPs) to develop, optimize, and scale manufacturing from preclinical through commercialization.
- Apply risk assessments and Quality by Design (QbD) to define design space and 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 to build reliable, scalable supply.
- Establish, evaluate, and manage CSP partnerships (contract negotiation, performance oversight, issue resolution).
- Ensure cGMP compliance; oversee deviations and change management; partner with Quality/Regulatory on filing impact.
- Lead CMC timeline/deliverables and documentation for regulatory submissions and inspections.
- Provide cross-functional leadership and technical expertise for internal teams and external diligence.
Education/Experience/Skills:
- Ph.D. in Synthetic Organic Chemistry or related field.
- 8–9+ years API development/manufacturing experience in pharma/biotech; 8+ years in a scientific role (or equivalent education/experience).
- Leadership managing projects with global contract CDMOs.
- Small-molecule development manufacturing experience (upstream/downstream); strong control strategy knowledge.
- FDA and ICH knowledge for small-molecule drug substance.
- Organic synthesis and API development understanding (pre-IND through NDA).
- CMC expertise for regulatory filings (e.g., IND to NDA) and cGMP experience.
- Strong communication/presentation; ability to direct internal/external collaborators.
- Negotiation, influence, problem-solving, conflict resolution, and vision-setting.
Benefits:
- Competitive base; eligible for discretionary bonus and equity awards.
- Medical, dental, vision insurance; employer-paid life/disability/travel/EAP.
- 401(k) with 1:1 match up to 5%; Employee Stock Purchase Plan.
- 15+ vacation days; 13–15 paid holidays; 10 paid sick time.
- Paid parental leave; tuition assistance.
Salary Range:
$154,200—$192,700 USD