What are the responsibilities and job description for the Senior Manager Quality Control position at Acadia Pharmaceuticals Inc.?
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 or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary:
The Senior Manager, Quality Control is responsible for Quality oversight of analytical methods and specifications used to test and release Acadia’s products. This position assists in the establishment of commercial analytical methods used to support manufacturing, release, and stability testing that are conducted at Acadia drug substance (DS) and drug product (DP) Contract Service Providers (CSPs). Responsible for the Quality oversight of CSPs performing GMP analytical testing and review of analytical method validations/transfers between laboratories. This position will be responsible for the quality review of release testing and stability data of DS and DP. Coordinate efforts with CSPs to report and trend analytical test results in a timely manner. This position will also be responsible for the Quality review of analytical technical reports and documents intended for regulatory submissions.
Primary Responsibilities:
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. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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 talentacquisition@acadia-pharm.com 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.
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 or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary:
The Senior Manager, Quality Control is responsible for Quality oversight of analytical methods and specifications used to test and release Acadia’s products. This position assists in the establishment of commercial analytical methods used to support manufacturing, release, and stability testing that are conducted at Acadia drug substance (DS) and drug product (DP) Contract Service Providers (CSPs). Responsible for the Quality oversight of CSPs performing GMP analytical testing and review of analytical method validations/transfers between laboratories. This position will be responsible for the quality review of release testing and stability data of DS and DP. Coordinate efforts with CSPs to report and trend analytical test results in a timely manner. This position will also be responsible for the Quality review of analytical technical reports and documents intended for regulatory submissions.
Primary Responsibilities:
- Review and evaluate analytical test results for DS and DP
- Review and author analytical method protocols and validations for commercialized products
- Review and author analytical transfer protocols and reports between laboratories
- Author stability protocols and reports, including trending analysis of all data
- Negotiate and/or review stability related agreements
- Author and review analytical data summaries to support batch release and stability assessments
- Assist in the review of reports for regulatory filings
- Interact with CSPs to facilitate stability testing at contract laboratories for Acadia projects
- Coordinate stability studies including reporting of test results
- Familiar with extractable and leachable testing, container closure and packaging qualification and integrity testing, and cleaning verification method development and validation
- Conduct and document analytical deviations, out-of-specification (OOS), out-of-trend (OOT) investigations, and CAPA reports following SOPs and GMP guidelines
- Maintain training records per GMP training requirements
- Ability to maintain effectiveness in a changing environment
- Set high standards and assume responsibility for scheduling and successfully completing assignments and tasks as required by company time lines
- Interact and collaborate effectively with staff and CSPs
- Assist with data review at CSPs
- Assist with routine GMP audits of CSPs
- BA/BS in chemistry or biochemistry with 8 years of experience in a pharmaceutical company environment is required
- Demonstrated proficiency in analytical science by experience and/or education
- Experience in the review of DS and DP release and stability data, is desired
- Experience with stability, method development, validation and transfer related to the testing of DS and DP
- Experience working in a GMP environment, Quality Control and/or Quality Assurance
- Experience with the documentation of deviations and investigations in a GMP, quality controlled system
- Excellent written/oral communication and interpersonal skills
- Experience with CMC sections for regulatory filings
- Ability to negotiate and deal with others in a constructive manner
- Excellent organizational skills, focused self-starter, attention to details, team-oriented but able to work independently and proactively, and ability to multi-task
- Contract service provider experience is required
- Analytical Chemistry Manufacturing Controls (CMC) experience
- Knowledge of current Good Manufacturing Practices (GMPs)
- Experience in analytical development, validation and testing
- Knowledge of laboratory instruments (e.g. HPLC, GC, KF, IR, etc.)
- Statistical modeling experience
- Well organized
- Excellent written/oral communication skills
- Ability to travel 20% of time both domestically and internationally
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. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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 talentacquisition@acadia-pharm.com 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.
