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Senior Manager, Quality Control Clinical Programs And Lims Administration

Company

Aimmune Therapeutics
Address , Brisbane, 94005, Ca
Employment type
Salary
Expires 2023-06-27
Posted at 1 year ago
Job Description
Position: Senior Manager, Quality Control Clinical Programs and LIMS Administration
Reports to: Associate Director, Quality Control
Location: US (Remote)
Summary
The Quality Control candidate will be a part of the Analytical Development and Quality Control Team and support activities for Aimmune clinical drug substance and drug products including LIMS administration responsibilities. The candidate will lead and coordinate all QC activities related to clinical projects at contract testing laboratories such as those associated with the GMP release testing of Aimmune clinical products. The candidate will also provide support in the analysis, review, and trending of release data, support regulatory filings (IND, BLA and MAA), author SOPs, and participate in investigations and raw data audits from CTLs. Prior experience with LIMS administration and clinical and/or commercial quality control release testing/manufacturing development of pharmaceutical products is required. The individual should have demonstrated ability to work effectively in a virtual analytical development, quality control, and manufacturing environment is also a requirement for the position.
Specific Responsibilities:
Clinical Quality Control
  • Reconcile audit results from multiple sources and maintain records of completed audits.
  • Additional responsibilities maybe assigned, as required, or in consideration of candidate’s expertise and skills
  • Audit and review analytical data such as HPLC, ELISA and protein content from contract testing laboratories.
  • Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of GMP data for lot release and regulatory submissions.
  • Analyze and review quality control release, stability testing, and manufacturing data of Aimmune’s pharmaceutical products at CTLs and/or CMOs.
  • Participate in authoring and review of Analytical Development, Quality Control, Manufacturing control documents such as: standard operation procedures (SOPs), test methods ™, stability protocols and report, method validation/verification protocols, reports and technical reports, manufacturing process development reports, investigation (OOS/OOT, deviations, LIRs, and INCs) reports.
  • Coordinate and lead QC related activities at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs) associated Clinical programs.
  • Prepare and review batch analysis and trend charts for internal reports and regulatory submissions.
  • Prepare and review manufacturing process development studies for internal reports and regulatory submissions.
  • Prepare and arrange QC meeting minutes, Sample/critical reagent shipment forms/memos, and other routine QC documentations as needed
LIMS Administration
  • Participate in system validation by drafting, reviewing and\or executing test scripts.
  • The System Administrator will apply analytical, communication, and problem-solving skills to help identify, communicate, and resolve issues
  • Maintains application Subject Matter Expert (SME) knowledge by staying current on software capabilities, issues, availability of new functionality, and updates from the software vendor.
  • Creates system reports per end user and management requests
  • Troubleshoot software errors, document problems and resolutions, and assessing impact of issues
  • Author, review and approve SOPs, protocols, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards
  • Provides system training to cross-functional departments.
  • Support system upgrades and enhancements
  • Update and create master data.
  • Responsible for identifying and implementing system improvements to optimize performance and uptime in a manner consistent with organizational goals, industry best practices, and regulatory requirements (e.g. FDA, ICH)
Qualifications / Requirements:
  • B.S. or advanced degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 10 years relevant experience in pharmaceutical development in Quality Control, Analytical Development, or Manufacturing function.
  • Experience in a GMP oriented environment and Quality Control related activities.
  • Prior experience reviewing and analyzing GMP data for analytical methods.
  • Prior experience in analytics for biopharmaceutical/biologics is preferred.
  • Prior experience with writing SOPs and other QC control documents is required.
  • Prior experience with contributing support to regulatory filing (IND, BLA, NDA or MAA).
  • Familiarity with Empower and SoftMax pro software is a plus.
  • Strong knowledge of systems and networking software, hardware, and networking protocols.
  • Experience in participation in development, validation, transfer, testing with chromatographic (HPLC), biophysical methods, and immunologic methods (ELISA).
  • Previous LIMS implementation and administration experience.
Preferred Experience, Special Skills, Knowledge:
  • Communicates effectively with supervisors, colleagues and subordinates
  • Experience with use of Excel or comparable software solutions for management of QC, Manufacturing data
  • A plus, experience with JMP, iStability, and/or Minitab or other software for statistical analysis of analytical data
  • Time management skills, ability to elevate relevant issues to project lead
  • Accuracy and attention to detail
  • Excellent cross-functional team participation skills
  • Ability to effectively prioritize and deliver on tight timelines.
  • Excellent written and verbal communication skills
  • Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment

About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and food digestion & absorption. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.