Director, Pharmaceutical Stability
Acadia Pharmaceuticals, San Diego, CA, United States
Overview
About Acadia Pharmaceuticals: Acadia is committed to turning scientific promise into meaningful innovation for underserved neurological and rare disease communities. The company’s portfolio includes FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome, with a pipeline spanning mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, and earlier-stage programs addressing other patient needs. This position is based in San Diego, CA or Princeton, NJ, with a hybrid model requiring three days per week in the office.
Position The Director, Pharmaceutical Stability leads and oversees outsourced stability testing activities across Acadia’s drug development portfolio, from early development through commercialization. This role manages multiple contract service providers (CSPs), ensuring delivery of high-quality, cGMP-compliant stability studies. Responsibilities include negotiating and overseeing vendor agreements, reviewing and approving stability protocols and reports, and aligning with global regulatory expectations. The role also contributes as the Analytical Development SME for regulatory submissions, stability trending, and OOS/OOT investigations.
Primary Responsibilities
Continue to develop and revise Acadia policies related to performing stability testing throughout the drug development stages
Develops stability protocol for intermediates, APIs and drug products:
Draft, review and/or approves stability protocols
Draft, review and/or approves stability-related chemistry, manufacturing and control (CMC) sections of regulatory documentation (such as 3.2.P.8 and 3.2.S7)
Provides oversight of testing at CSPs:
Negotiate and/or review and approve stability-related agreements
Actively monitors stability programs at CSPs
Reviews stability data for trends, out-of-specification (OOS) and out-of-trend (OOT) results
Reports delays in receiving stability data from CSP to management
Business Owner of Acadia implemented stability software (such as SLIM and SLIM Stat)
Liaises 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
Meet with project teams to identify drug substance, intermediates, and drug product batches required to be added to stability programs
Manage the activities of FTEs and/or consultants assigned to the Stability Group
Develop FTEs to grow within Acadia
Oversee laboratory investigations related to stability studies:
Investigates and/or review CSP OOS/OOT stability investigations
Assesses performance of CSP laboratory for accuracy and technical expertise
Education/Experience/Skills
BS in Chemistry or related field. A minimum of 20 years progressively responsible experience with a focus on drug substance and drug product stability studies, supervise analytical testing and stability protocols/reports. A combination of relevant education and applicable job experience may be considered.
Must Have
Experience with oversight management of CSP analytical laboratory and writing stability sections for regulatory submissions
Good understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH guidance, 21 CFR Part 211, 21 CFR Part 11)
Working knowledge of USP/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
Effective verbal and written communication; ability to gain cooperation across functional areas and present technical information
Ability to lead a cooperative team and allocate resources to meet goals
Ability to travel up to 20% domestically and internationally
Scope Provides guidance to subordinates and/or manages department sections to achieve goals in accordance with established policies. Follows processes and policies to obtain solutions, determining resource use to meet schedules and goals. Addresses issues of diverse scope requiring evaluation of multiple factors and understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may impact costs and short-term goals.
Physical Requirements In a standard office environment, the role requires standing, walking, sitting, using hands, reaching, climbing/balancing, stooping/kneeling/crouching, seeing, talking and hearing. May occasionally lift up to 20 pounds. Travel by car or airplane up to 20% of the time and may require after-hours work due to travel schedules or business issues.
Compensation and Benefits In addition to base salary, this position is eligible for discretionary bonus and equity awards. Salary range: $178,000–$223,000 USD. Actual amounts vary by experience, performance, and location.
What We Offer (US-based Employees)
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13–15 paid holidays, including office closure between December 24 and January 1
10 days of paid sick time
Paid parental leave benefit
Tution assistance
EEO Statement Acadia is an equal employment opportunity employer. We encourage a diverse, inclusive workforce and support reasonable accommodations throughout the interview process. See our Privacy Policy for applicable information for California, Canadian, and EEA/UK/Serbia applicants. If you are a qualified individual with a disability, you may request accommodation by contacting talentacquisition@acadia-pharm.com or 858-261-2923.
Notice to Recruiters The Talent Acquisition team manages the recruitment process. Acadia does not accept resumes from recruiters or search firms without an executed search agreement. Resumes sent without an agreement will not obligate Acadia to future employment or remuneration to the recruiter.
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Position The Director, Pharmaceutical Stability leads and oversees outsourced stability testing activities across Acadia’s drug development portfolio, from early development through commercialization. This role manages multiple contract service providers (CSPs), ensuring delivery of high-quality, cGMP-compliant stability studies. Responsibilities include negotiating and overseeing vendor agreements, reviewing and approving stability protocols and reports, and aligning with global regulatory expectations. The role also contributes as the Analytical Development SME for regulatory submissions, stability trending, and OOS/OOT investigations.
Primary Responsibilities
Continue to develop and revise Acadia policies related to performing stability testing throughout the drug development stages
Develops stability protocol for intermediates, APIs and drug products:
Draft, review and/or approves stability protocols
Draft, review and/or approves stability-related chemistry, manufacturing and control (CMC) sections of regulatory documentation (such as 3.2.P.8 and 3.2.S7)
Provides oversight of testing at CSPs:
Negotiate and/or review and approve stability-related agreements
Actively monitors stability programs at CSPs
Reviews stability data for trends, out-of-specification (OOS) and out-of-trend (OOT) results
Reports delays in receiving stability data from CSP to management
Business Owner of Acadia implemented stability software (such as SLIM and SLIM Stat)
Liaises 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
Meet with project teams to identify drug substance, intermediates, and drug product batches required to be added to stability programs
Manage the activities of FTEs and/or consultants assigned to the Stability Group
Develop FTEs to grow within Acadia
Oversee laboratory investigations related to stability studies:
Investigates and/or review CSP OOS/OOT stability investigations
Assesses performance of CSP laboratory for accuracy and technical expertise
Education/Experience/Skills
BS in Chemistry or related field. A minimum of 20 years progressively responsible experience with a focus on drug substance and drug product stability studies, supervise analytical testing and stability protocols/reports. A combination of relevant education and applicable job experience may be considered.
Must Have
Experience with oversight management of CSP analytical laboratory and writing stability sections for regulatory submissions
Good understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH guidance, 21 CFR Part 211, 21 CFR Part 11)
Working knowledge of USP/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
Effective verbal and written communication; ability to gain cooperation across functional areas and present technical information
Ability to lead a cooperative team and allocate resources to meet goals
Ability to travel up to 20% domestically and internationally
Scope Provides guidance to subordinates and/or manages department sections to achieve goals in accordance with established policies. Follows processes and policies to obtain solutions, determining resource use to meet schedules and goals. Addresses issues of diverse scope requiring evaluation of multiple factors and understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may impact costs and short-term goals.
Physical Requirements In a standard office environment, the role requires standing, walking, sitting, using hands, reaching, climbing/balancing, stooping/kneeling/crouching, seeing, talking and hearing. May occasionally lift up to 20 pounds. Travel by car or airplane up to 20% of the time and may require after-hours work due to travel schedules or business issues.
Compensation and Benefits In addition to base salary, this position is eligible for discretionary bonus and equity awards. Salary range: $178,000–$223,000 USD. Actual amounts vary by experience, performance, and location.
What We Offer (US-based Employees)
Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
Employer-paid life, disability, business travel and EAP coverage
401(k) Plan with a fully vested company match 1:1 up to 5%
Employee Stock Purchase Plan with a 2-year purchase price lock-in
15+ vacation days
13–15 paid holidays, including office closure between December 24 and January 1
10 days of paid sick time
Paid parental leave benefit
Tution assistance
EEO Statement Acadia is an equal employment opportunity employer. We encourage a diverse, inclusive workforce and support reasonable accommodations throughout the interview process. See our Privacy Policy for applicable information for California, Canadian, and EEA/UK/Serbia applicants. If you are a qualified individual with a disability, you may request accommodation by contacting talentacquisition@acadia-pharm.com or 858-261-2923.
Notice to Recruiters The Talent Acquisition team manages the recruitment process. Acadia does not accept resumes from recruiters or search firms without an executed search agreement. Resumes sent without an agreement will not obligate Acadia to future employment or remuneration to the recruiter.
#J-18808-Ljbffr