Compensation: 125.000 - 150.000
Overview
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. Location considerations: Princeton, NJ; San Diego, CA.
Position Summary
Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMOs) and other third-party suppliers for products as identified. Responsible for tracking ongoing manufacturing schedules to ensure commercial supply levels are maintained and inventory targets are met. Responsible for technical and business evaluation of the manufacturing network.
Primary Responsibilities
- Team and Project Leadership, capable of leading manufacturing activities and coordinating activities across a matrix team. A SME in DP manufacturing, knowledgeable in development, quality, and regulatory requirements for manufacturing.
- Manage all aspects of DP Manufacturing from authoring and revision of manufacturing documents (MBRs, Protocols, QRAs, etc.), oversight of manufacturing operation, managing deviations, investigations, and relevant change actions, supporting product release, and ensuring the finished product arrives in warehouse for distribution.
- Responsible for DP vendor selection process for new commercial suppliers or for alternative suppliers.
- Develops and maintains good working relationships with contract manufacturers.
- Develop and maintain Drug Product manufacturing production timeline that is resource and budget loaded to ensure near real time tracking of production and resource.
- Coordinate periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.
- Maintains and follow through a consolidated Acadia Manufacturing action log to ensure all manufacturing related actions are completed on time.
- Provide onsite process coverage as person-in-plant as needed.
- Develops, collects appropriate internal and external metrics to measure CMO and Acadia’s performance.
- Communicates manufacturing or technology related issues and information to Manufacturing production team members, TDO stakeholders, and other members of the project team.
- Supervise, train and mentor personnel as needed.
- Prepare Annual Product Reports with Manufacturing CMOs according to Acadia’s needs.
- Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings.
- Works with Quality Group and Acadia Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
- With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
Education/Experience/Skills
Education/Experience/Skills: BS, MS, or PhD in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. A minimum of 12 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.
- Contract service provider experience.
- Strong understanding is required of biopharmaceutical manufacturing including regulatory filings and quality inspections and audits.
- Strong business acumen.
- Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
- Extensive knowledge of current Good Manufacturing Practices (cGMPs).
- Able to operate effectively and with a strong sense of urgency in a fast-paced environment.
- Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
- Domestic and International travel is required for this role.
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 30% of the time and work after hours if required by travel schedule or business issues.
Compensation and Benefits
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
$174,100—$217,600 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
- Tution 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.
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 or .
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.
California Applicants: Please see Additional Information for California Residents within our Privacy Policy.
Canadian Applicants: Please see Additional Information for Canadian Residents within our Privacy Policy.
Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
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