Senior Manager, Packaging and Serialization

Acadia Pharmaceuticals Inc.•San Diego, CA

9d•Hybrid

About The Position

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. Responsible for coordination of packaging (package design), artwork, and serialization with commercial Drug Product Contract Manufacturing organizations (CMO’s), and other third party suppliers for products as identified. Subject matter expert in the field of serialization to oversee our CMOs running commercial and Acadia data management and integration. Experienced in the technical aspects of product introduction into the EU and other global markets as related to serialization, package design, and local requirements.

Requirements

BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. Scientific advanced degree a plus. A minimum of 8 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.
Contract service provider experience.
Strong understanding is required of the biopharmaceutical serialization and packaging process
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.
Experience in a cGMP environment
Capability to communicate efficiently and effective about issues of a complex (technological and scientific) nature
Attention for detail

Responsibilities

Develops and maintains good working relationships with both internal stakeholders and contract manufacturers.
Acquires and maintains scientific and technological knowledge and background of existing and new pharmaceutical (surface) serialization technologies to ensure our CMOs are aligned. Verifies CMO serialization technologies and ensures compliance with pharmaceutical regulatory requirements (EU FMD and DSCSA).
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.
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.
Provide onsite process coverage as person-in-plant as needed
Develops, collects appropriate internal and external metrics to measure CMO and Acadia performance.
Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.
Supervise, train and mentor personnel as needed.

Benefits

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