Director, Pharmaceutical Stability
Acadia Pharmaceuticals
4 hours ago
Remote friendly (San Diego, CA)
United States
Operations
Primary Responsibilities:
- Continue to develop and revise Acadia policies related to performing stability testing throughout the 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 of regulatory documentation (e.g., 3.2.P.8 and 3.2.S7).
- Provide oversight of testing at contract service providers (CSPs):
- Negotiate and/or review and approve stability-related agreements.
- Actively 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 Acadia’s stability software (e.g., SLIM, SLIM Stat).
- Liaise with pharmaceutical development, manufacturing, quality, and regulatory counterparts 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 and meet with project teams to identify batches to add to stability programs.
- Manage the activities of FTEs and/or consultants assigned to the Stability Group; develop FTEs.
- Oversee laboratory investigations related to stability studies:
- Investigate and/or review CSP OOS/OOT stability investigations.
- Assess CSP laboratory performance for accuracy and technical expertise.
Education/Experience/Skills:
- BS in Chemistry (or related field).
- Minimum of 20 years progressively responsible experience focused on drug substance and drug product stability studies, supervising analytical testing and stability protocols/reports (a combination of relevant education and experience may be considered).
Must possess:
- Experience overseeing CSP analytical laboratories and writing stability sections for regulatory submissions.
- Good understanding of GMP environments and regulatory guidance/regulations (ICH; 21 CFR Part 211; 21 CFR Part 11).
- Working knowledge of USP and EP, and FDA/ICH/WHO stability-related 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.
- Strong communication skills (verbal/written) and ability to lead cooperative cross-functional efforts.
- Ability to travel ~20% domestically and internationally.
Scope:
- Provides guidance and/or manages a department section to achieve goals, meet schedules, resolve problems, and evaluate diverse issues and factors.
Physical requirements:
- Standard office physical abilities; occasionally lift/move up to 20 lbs; independent travel by car/airplane up to 20%; may work after hours when required by travel/business.
Benefits (as stated):
- Competitive base, bonus, and new hire/ongoing equity packages.
- Medical, dental, and vision insurance; employer-paid life, disability, business travel, and EAP coverage.
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan (2-year purchase price lock-in).
- 15+ vacation days; 13–15 paid holidays (office closure Dec 24–Jan 1); 10 paid sick days; paid parental leave; tuition assistance.
Application instructions:
- Not provided in the text.
- Continue to develop and revise Acadia policies related to performing stability testing throughout the 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 of regulatory documentation (e.g., 3.2.P.8 and 3.2.S7).
- Provide oversight of testing at contract service providers (CSPs):
- Negotiate and/or review and approve stability-related agreements.
- Actively 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 Acadia’s stability software (e.g., SLIM, SLIM Stat).
- Liaise with pharmaceutical development, manufacturing, quality, and regulatory counterparts 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 and meet with project teams to identify batches to add to stability programs.
- Manage the activities of FTEs and/or consultants assigned to the Stability Group; develop FTEs.
- Oversee laboratory investigations related to stability studies:
- Investigate and/or review CSP OOS/OOT stability investigations.
- Assess CSP laboratory performance for accuracy and technical expertise.
Education/Experience/Skills:
- BS in Chemistry (or related field).
- Minimum of 20 years progressively responsible experience focused on drug substance and drug product stability studies, supervising analytical testing and stability protocols/reports (a combination of relevant education and experience may be considered).
Must possess:
- Experience overseeing CSP analytical laboratories and writing stability sections for regulatory submissions.
- Good understanding of GMP environments and regulatory guidance/regulations (ICH; 21 CFR Part 211; 21 CFR Part 11).
- Working knowledge of USP and EP, and FDA/ICH/WHO stability-related 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.
- Strong communication skills (verbal/written) and ability to lead cooperative cross-functional efforts.
- Ability to travel ~20% domestically and internationally.
Scope:
- Provides guidance and/or manages a department section to achieve goals, meet schedules, resolve problems, and evaluate diverse issues and factors.
Physical requirements:
- Standard office physical abilities; occasionally lift/move up to 20 lbs; independent travel by car/airplane up to 20%; may work after hours when required by travel/business.
Benefits (as stated):
- Competitive base, bonus, and new hire/ongoing equity packages.
- Medical, dental, and vision insurance; employer-paid life, disability, business travel, and EAP coverage.
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan (2-year purchase price lock-in).
- 15+ vacation days; 13–15 paid holidays (office closure Dec 24–Jan 1); 10 paid sick days; paid parental leave; tuition assistance.
Application instructions:
- Not provided in the text.