Senior Manager, Quality Control

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