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Director Packaging and Serialization

Acadia Pharmaceuticals Inc.
United States, New Jersey, Princeton
Feb 25, 2025

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director, Packaging and Serialization is 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.

Primary 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.


Education/Experience/Skills:



  • BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. Scientific advanced degree a plus. A minimum of 10 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry. An equivalent combination of relevant education and experience may be considered.
  • 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
  • Fluent in English, preferably French and/or German
  • Capability to communicate efficiently and effective about issues of a complex (technological and scientific) nature
  • Attention for detail


Scope:

Manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems; may provide direction to and review of, managers, supervisors, or employees. Works on abstract problems that may cross functional areas. Interacts with management on matters concerning functional area. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.

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 25% of the time and work after hours if required by travel schedule or business issues.

#LI-HYBRID #LI-BG1

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 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 [emailprotected] 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.

Notice for California Applicants: Please see our California Applicant Privacy Notice 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 absence of an executed search agreement will not obligate Acadia in any way with the 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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