Director, Pharmaceutical Stability

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.

Primary Responsibilities

• Continue to develop and revise Acadia policies related to performing stability testing throughout the drug development stages
• Develop stability protocol for intermediates, APIs and drug products: draft, review and/or approve stability protocols; draft, review and/or approve stability related chemistry, manufacturing and control (CMC) sections of regulatory documentation (such as 3.2.P.8 and 3.2.S7)
• Provide oversight of testing at 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 CSP to management
• Business owner of Acadia implemented stability software such as SLIM and 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
• 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: 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 with a focus on drug substance and drug product stability studies, supervising 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 and 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.

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.

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