**Who this is for** This leadership position is for an expert in pharmaceutical stability with extensive experience in overseeing outsourced stability testing a
Work type: hybrid
Location: Princeton, New Jersey, United States; San Diego, California, United States
Salary: $178,000 – $223,000/yr
Type: Full-time
**Who this is for** This leadership position is for an expert in pharmaceutical stability with extensive experience in overseeing outsourced stability testing and managing contract service providers. You will be responsible for ensuring cGMP-compliant stability studies from early development through commercialization. **Key highlights** You will lead and oversee stability testing activities, manage multiple contract service providers, and ensure high-quality, cGMP-compliant stability studies. This role also involves developing stability policies, contributing to regulatory submissions, and providing expertise on OOS/OOT investigations. **You might be a good fit if you...** - Hold a BS in Chemistry or a related field, with a minimum of 20 years of experience focused on drug substance and drug product stability studies. - Have experience managing analytical testing and stability protocols/reports, with oversight of CSP analytical laboratories. - Possess a strong understanding of GMP environments, regulatory guidance (ICH, FDA), and pharmacopeias (USP, EP). - Are skilled in drafting, reviewing, and approving stability protocols, reports, and CMC sections for regulatory documentation.
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 or Princeton, NJ. 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:
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
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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: