Job Description
About Acadia Pharmaceuticals
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.
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 possess:
- 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
Scope:
Provides guidance to subordinates and/or manages department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.
Physical Requirements:
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 20% of the time and work after hours if required by travel schedule or business issues
#LI-HYBRID #LI-SM1
In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
Salary Range
$178,000—$223,000 USD
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 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
California Applicants: Please see Additional Information for California Residents within our Privacy Policy.
Canadian Applicants: Please seeAdditional Information for Canadian Residents within our Privacy Policy.
Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
