Senior Manager, Quality Control

San Diego, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Please note that this position is based in San Diego CA. Acadias 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 Acadias products. This position assists in establishing commercial analytical methods to support manufacturing release and stability testing conducted at Acadias 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.

#LI-HYBRID #LI-BG1

Required Experience:

Senior Manager

Please note that this position is based in San Diego CA. Acadias 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 Acadias products. This position a...

Please note that this position is based in San Diego CA. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary:

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