Director, Pharmaceutical Stability
Acadia Pharmaceuticals
2 days ago
Remote friendly (Princeton, NJ)
United States
Operations
Primary Responsibilities:
- Develop and revise Acadia policies for performing stability testing throughout drug development stages.
- Develop stability protocols for intermediates, APIs, and drug products:
- Draft, review, and/or approve stability protocols.
- Draft, review, and/or approve stability-related CMC sections in regulatory documentation (e.g., 3.2.P.8 and 3.2.S7).
- Oversee outsourced testing at Contract Service Providers (CSPs):
- Negotiate and/or review and approve stability-related agreements.
- Monitor stability programs at CSPs.
- Review stability data for trends, out-of-specification (OOS), and out-of-trend (OOT) results.
- Report delays in receiving stability data from CSPs to management.
- Serve as business owner for stability software (e.g., SLIM, SLIM Stat).
- Liaise with pharmaceutical development, manufacturing, quality, and regulatory to develop stability protocols for regulatory submissions.
- Draft, review, and/or approve stability reports supporting shelf-life, expiry, and retest period.
- Provide trending of stability data.
- Meet with project teams to identify drug substance, intermediate, and drug product batches to add to stability programs.
- Manage FTEs and/or consultants in the Stability Group; develop FTEs.
- Oversee laboratory investigations related to stability studies, including investigating and/or reviewing CSP OOS/OOT investigations and assessing CSP lab performance.
Education/Experience:
- BS in Chemistry (or related field). Minimum 20 years progressively responsible experience in drug substance and drug product stability studies, including supervision of analytical testing and stability protocols/reports (or combination of education and relevant experience).
Must possess:
- Experience managing oversight of CSP analytical laboratories and writing stability sections for regulatory submissions.
- Strong GMP knowledge and regulatory requirements (e.g., ICH guidance, 21 CFR Part 211, 21 CFR Part 11).
- Working knowledge of USP and EP, and FDA/ICH/WHO stability guidance.
- Strong negotiating skills.
- Excellent organizational and documentation skills.
- Experience authoring technical stability reports and CMC sections for regulatory filings.
- Ability to manage change in a dynamic environment.
- Effective communication and presentation skills; ability to gain cooperation.
- Ability to lead cooperative teams and prioritize process/resource decisions.
- Travel up to 20% domestically and internationally.
Scope:
- Provides guidance and/or manages a department section to achieve goals, schedules, and problem resolution; uses established policies/processes to select methods and allocate resources.
Benefits:
- Medical, dental, vision insurance; employer-paid life, disability, business travel, and EAP coverage.
- 401(k) with 1:1 match up to 5%.
- Employee Stock Purchase Plan with 2-year purchase price lock-in.
- 15+ vacation days; 13–15 paid holidays (including office closure between Dec 24 and Jan 1); 10 paid sick time.
- Paid parental leave; tuition assistance.
- Discretionary bonus and equity awards (amounts vary by experience/performance/location).
Application instructions:
- Not specified in the provided text.
- Develop and revise Acadia policies for performing stability testing throughout drug development stages.
- Develop stability protocols for intermediates, APIs, and drug products:
- Draft, review, and/or approve stability protocols.
- Draft, review, and/or approve stability-related CMC sections in regulatory documentation (e.g., 3.2.P.8 and 3.2.S7).
- Oversee outsourced testing at Contract Service Providers (CSPs):
- Negotiate and/or review and approve stability-related agreements.
- Monitor stability programs at CSPs.
- Review stability data for trends, out-of-specification (OOS), and out-of-trend (OOT) results.
- Report delays in receiving stability data from CSPs to management.
- Serve as business owner for stability software (e.g., SLIM, SLIM Stat).
- Liaise with pharmaceutical development, manufacturing, quality, and regulatory to develop stability protocols for regulatory submissions.
- Draft, review, and/or approve stability reports supporting shelf-life, expiry, and retest period.
- Provide trending of stability data.
- Meet with project teams to identify drug substance, intermediate, and drug product batches to add to stability programs.
- Manage FTEs and/or consultants in the Stability Group; develop FTEs.
- Oversee laboratory investigations related to stability studies, including investigating and/or reviewing CSP OOS/OOT investigations and assessing CSP lab performance.
Education/Experience:
- BS in Chemistry (or related field). Minimum 20 years progressively responsible experience in drug substance and drug product stability studies, including supervision of analytical testing and stability protocols/reports (or combination of education and relevant experience).
Must possess:
- Experience managing oversight of CSP analytical laboratories and writing stability sections for regulatory submissions.
- Strong GMP knowledge and regulatory requirements (e.g., ICH guidance, 21 CFR Part 211, 21 CFR Part 11).
- Working knowledge of USP and EP, and FDA/ICH/WHO stability guidance.
- Strong negotiating skills.
- Excellent organizational and documentation skills.
- Experience authoring technical stability reports and CMC sections for regulatory filings.
- Ability to manage change in a dynamic environment.
- Effective communication and presentation skills; ability to gain cooperation.
- Ability to lead cooperative teams and prioritize process/resource decisions.
- Travel up to 20% domestically and internationally.
Scope:
- Provides guidance and/or manages a department section to achieve goals, schedules, and problem resolution; uses established policies/processes to select methods and allocate resources.
Benefits:
- Medical, dental, vision insurance; employer-paid life, disability, business travel, and EAP coverage.
- 401(k) with 1:1 match up to 5%.
- Employee Stock Purchase Plan with 2-year purchase price lock-in.
- 15+ vacation days; 13–15 paid holidays (including office closure between Dec 24 and Jan 1); 10 paid sick time.
- Paid parental leave; tuition assistance.
- Discretionary bonus and equity awards (amounts vary by experience/performance/location).
Application instructions:
- Not specified in the provided text.