Director, Pharmaceutical Stability

Please note that this position is based in San Diego CA or Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.

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

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