Acadia Pharmaceuticals Inc.
Senior Manager, Quality Control
Acadia Pharmaceuticals Inc., San Diego, California, United States, 92189
Get AI-powered advice on this job and more exclusive features.
Pay found in job post Retrieved from the description.
Base pay range $112,500.00/yr - $140,600.00/yr
Direct message the job poster from Acadia Pharmaceuticals Inc.
Talent Advisor for Life Sciences | Finding Talent with the Right Chemistry—Literally About Acadia Pharmaceuticals 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. Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary: Responsible for Quality oversight of analytical methods and specifications used to test and release Acadia’s products. This position assists in establishing commercial analytical methods to support manufacturing, release, and stability testing conducted at Acadia's 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 reviewing the quality of release testing and stability data for 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
Education/Experience/Skills:
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
Must possess:
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
Physical Requirements 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.
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 $112,500—$140,600 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
Tuition 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 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 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.
Seniority level
Seniority level Mid-Senior level
Employment type
Employment type Full-time
Job function
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Acadia Pharmaceuticals Inc. by 2x
Manager/Sr. Manager, Quality Assurance (GxP) Compliance and Quality Assurance Manager Sr. Manager, Supplier Quality & Process Validation, iovera Supply Chain Quality Manager -Propulsion San Diego, CA $60,000 - $100,000 1 year ago
QUALITY ASSURANCE MANAGER (JANITORIAL - 2ND SHIFT) We’re unlocking community knowledge in a new way. Experts add insights directly ...
#J-18808-Ljbffr
Pay found in job post Retrieved from the description.
Base pay range $112,500.00/yr - $140,600.00/yr
Direct message the job poster from Acadia Pharmaceuticals Inc.
Talent Advisor for Life Sciences | Finding Talent with the Right Chemistry—Literally About Acadia Pharmaceuticals 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. Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary: Responsible for Quality oversight of analytical methods and specifications used to test and release Acadia’s products. This position assists in establishing commercial analytical methods to support manufacturing, release, and stability testing conducted at Acadia's 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 reviewing the quality of release testing and stability data for 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
Education/Experience/Skills:
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
Must possess:
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
Physical Requirements 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.
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 $112,500—$140,600 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
Tuition 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 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 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.
Seniority level
Seniority level Mid-Senior level
Employment type
Employment type Full-time
Job function
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Acadia Pharmaceuticals Inc. by 2x
Manager/Sr. Manager, Quality Assurance (GxP) Compliance and Quality Assurance Manager Sr. Manager, Supplier Quality & Process Validation, iovera Supply Chain Quality Manager -Propulsion San Diego, CA $60,000 - $100,000 1 year ago
QUALITY ASSURANCE MANAGER (JANITORIAL - 2ND SHIFT) We’re unlocking community knowledge in a new way. Experts add insights directly ...
#J-18808-Ljbffr