Senior Manager, Manufacturing

About Acadia Pharmaceuticals

The Senior Manager, Manufacturing, is responsible for oversight of commercial Contract Manufacturing organizations (CMO’s), and other third party suppliers for products as identified, including the transfer of processes from R&D/Product development to commercial third party suppliers primarily in the EU but could include other areas of the globe. Responsible for oversight of ongoing manufacturing schedules to ensure both development and commercial supply levels are maintained and inventory targets are met.   Ensures that manufacturing activities meet the needs of all internal and external constituencies with an emphasis on process, quality, budget control and profitability.

Primary Responsibilities:

• Develops and maintains good working relationships with contract manufacturers.
• Support the management of CMO contracts
• Develop SOP’s and work processes needed for Commercial Manufacturing
• Works with CMOs to diagnose and correct process issues.
• Identifies, evaluates and selects CMOs for the manufacture of Commercial products
• Develops, collects appropriate metrics to measure CMO performance; leads CMO partnership teams.
• Works with Quality Group to determine the impact of process deviations and works towards resolutions
• Develops timelines, goals, and deliverables for API, Drug product and related manufacturing processes.
• Optimizes the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs.
• Assists in developing drug product and drug substance sourcing strategies.
• With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
• Tracks deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.
• Initiates and coordinates the preparation of CMC documentation as required
• Collaborates with Regulatory Affairs and other groups to support product filings.
• Assists in contract site preparation activities for regulatory inspections.
• Supports interdisciplinary working teams with recommendations, advice and action plans for manufacturing related issues.
• Provide onsite process coverage as person-in-pant as needed
• Develops systems and maintain compliance to import/export regulatory requirements.
• Communicates manufacturing or technology related issues and information to committees, teams and interested groups within the company.
• Train and mentor personnel as needed.

Education/Experience/Skills:

BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience.  Masters or Ph.D. preferred.    Requires 8+ years of progressively responsible experience within the pharmaceutical/biotechnology industry.

Must possess:

• Contract service provider experience.
• Strong understanding is required of the biopharmaceutical drug development process including regulatory filings and quality inspections and audits.
• Extensive knowledge of regulations as they pertain to post-approval manufacturing process changes; site changes, etc.
• Domestic and Overseas Travel is required for this role.

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  Ability to travel by car or airplane independently up to 50% of the time both domestically, internationally, and work after hours if required by travel schedule or business issues.

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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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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.

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