20 days old

Manager Quality Control

ACADIA Pharmaceuticals
San Diego, CA 92101
  • Job Code
    117596465
ACADIA Pharmaceuticals

ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

Position Summary:

Responsible for Quality oversight of analytical methods and specifications used to test and release ACADIAs 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 pre-clinical through commercialized products
  • Review and author analytical transfer protocols and reports between laboratories
  • Author stability protocols and reports, including trending analysis of all data
  • 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, 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 five 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.
  • 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

Scope:

Provides guidance to department to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Establishes own operational objectives and work plans with senior management review. Selects methods, techniques, and evaluation criteria for obtaining results. Works on issues where analysis of situations or data requires an in-depth knowledge of functional area objectives and their impact on, and interaction with, other functions within the organization. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

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.


PI117596465

<b>ACADIA Pharmaceuticals</b><br/><br/>ACADIA Pharmaceuticals is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity</em><br/><br/><p><strong><u>Position Summary:</u></strong></p> <p>Responsible for Quality oversight of analytical methods and specifications used to test and release ACADIAs 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.</p> <p><strong><u>Primary Responsibilities:</u></strong></p> <ul> <li>Review and evaluate analytical test results for DS and DP</li> <li>Review and author analytical method protocols and validations for pre-clinical through commercialized products</li> <li>Review and author analytical transfer protocols and reports between laboratories</li> <li>Author stability protocols and reports, including trending analysis of all data</li> <li>Author and review analytical data summaries to support batch release and stability assessments</li> <li>Assist in the review of reports for regulatory filings</li> <li>Interact with CSPs to facilitate stability testing at contract laboratories for ACADIA projects</li> <li>Coordinate stability studies including reporting of test results</li> <li>Familiar with extractable and leachable testing, container closure and packaging qualification and integrity testing, and cleaning verification method development and validation</li> <li>Conduct and document analytical deviations, investigations, and CAPA reports following SOPs and GMP guidelines</li> <li>Maintain training records per GMP training requirements</li> <li>Ability to maintain effectiveness in a changing environment</li> <li>Set high standards and assume responsibility for scheduling and successfully completing assignments and tasks as required by company time lines</li> <li>Interact and collaborate effectively with staff and CSPs</li> <li>Assist with data review at CSPs</li> <li>Assist with routine GMP audits of CSPs</li> </ul> <p><strong><u>Education/Experience/Skills:</u></strong></p> <ul> <li>BA/BS in chemistry or biochemistry with five years of experience in a pharmaceutical company environment is required</li> <li>Demonstrated proficiency in analytical science by experience and/or education.</li> <li>Experience in the review of DS and DP release and stability data, is desired.</li> <li>Experience with stability, method development, validation and transfer related to the testing of DS and DP.</li> <li>Experience working in a GMP environment, Quality Control and/or Quality Assurance.</li> <li>Experience with the documentation of deviations and investigations in a GMP, quality controlled system</li> <li>Excellent written/oral communication and interpersonal skills.</li> <li>Ability to negotiate and deal with others in a constructive manner.</li> <li>Excellent organizational skills, focused self-starter, attention to details, team-oriented but able to work independently and proactively, and ability to multi-task.</li> <li>Contract service provider experience is required</li> </ul> <p> </p> <ul> <li>Must possess: <ul> <li>Analytical Chemistry Manufacturing Controls (CMC) experience</li> <li>Knowledge of current Good Manufacturing Practices (GMPs)</li> <li>Experience in analytical development, validation and testing</li> <li>Knowledge of laboratory instruments (e.g. HPLC, GC, KF, IR, etc.)</li> <li>Statistical modeling experience</li> <li>Well organized</li> <li>Excellent written/oral communication skills</li> </ul> </li> </ul> <p><strong><u>Scope:</u></strong></p> <p>Provides guidance to department to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Establishes own operational objectives and work plans with senior management review. Selects methods, techniques, and evaluation criteria for obtaining results. Works on issues where analysis of situations or data requires an in-depth knowledge of functional area objectives and their impact on, and interaction with, other functions within the organization. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.</p> <p> </p> <p><strong><u>Physical Requirements:</u></strong></p> <p>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. </p> <p><em><span style="font-weight: 400;"><br/></span></em></p> <img src="https://analytics.click2apply.net/v/QlDeXGUgWroOUV65io81p"> <p>PI117596465</p>

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Posted: 2020-01-30 Expires: 2020-03-01

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Manager Quality Control

ACADIA Pharmaceuticals
San Diego, CA 92101

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