Director, Pharmaceutical Stability

Acadia Pharmaceuticals Inc. • San Diego, CA

1d • Hybrid

About The Position

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.
Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
The Director, Pharmaceutical Stability leads and oversees outsourced stability testing activities across Acadia’s drug development portfolio, from early development through commercialization. The position is responsible for managing multiple contract service providers (CSPs), ensuring delivery of high‑quality, consistent, and cGMP‑compliant stability studies. Key responsibilities include negotiating and overseeing vendor agreements, reviewing and approving stability protocols and reports, and driving alignment with global regulatory expectations. The role also plays a critical part in evolving Acadia’s stability policies and serves as the Analytical Development subject matter expert (SME) for regulatory submissions, stability trending, and OOS/OOT investigations.

Requirements

• 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.
• 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 United States Pharmacopeia (USP) and European Pharmacopeia (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
• Skilled at effectively communicating (verbally and written) department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs
• Ability to travel 20% of time both domestically and internationally

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

Benefits

• 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 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Director