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Responsible for leadership and 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. 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.
- Develops and maintains good working relationships with contract manufacturers.
- Negotiate and manage CMO contracts
- Develop SOPs 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 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
- Assists in developing 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
- Supports interdisciplinary working teams with recommendations, advice and action plans for manufacturing related
- Provide onsite process coverage as person-in-plant as needed
- Develops systems and maintain compliance to import/export regulatory
- Communicates manufacturing or technology related issues and information to committees, teams and interested groups within the company.
- Supervise, train and mentor personnel as needed.
- BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. Masters or Ph.D. preferred.
- A desired10 years of progressively responsible experience within the pharmaceutical/biotechnology industry with 5 years in a leadership role.
- 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.
- Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
- Extensive knowledge of current Good Manufacturing Practices (cGMPs) and demonstrated experience in manufacturing process development for new drugs.
- Collaborative leader able to operate effectively and with a strong sense of urgency in a fast-paced
- Hands-on approach with a strategic and operational focus; capable decision maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes.
- Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational
- Domestic and Overseas Travel is required for this role.
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 25% of the time and work after hours if required by travel schedule or business issues.
What we offer you:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 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
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single 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 would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it 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 accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.