Senior Manager, Quality Control Clinical Programs and LIMS Administration
Aimmune Therapeutics
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Brisbane, CA, USA
Posted on Friday, April 8, 2022
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
- Coordinate and lead QC related activities at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs) associated Clinical programs.
- Audit and review analytical data such as HPLC, ELISA and protein content from contract testing laboratories.
- Reconcile audit results from multiple sources and maintain records of completed audits.
- Analyze and review quality control release, stability testing, and manufacturing data of Aimmune’s pharmaceutical products at CTLs and/or CMOs.
- 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.
- 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.
- 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.
- Prepare and arrange QC meeting minutes, Sample/critical reagent shipment forms/memos, and other routine QC documentations as needed
- Additional responsibilities maybe assigned, as required, or in consideration of candidate’s expertise and skills
LIMS Administration
- Update and create master data.
- Participate in system validation by drafting, reviewing and\or executing test scripts.
- Provides system training to cross-functional departments.
- Maintains application Subject Matter Expert (SME) knowledge by staying current on software capabilities, issues, availability of new functionality, and updates from the software vendor.
- Troubleshoot software errors, document problems and resolutions, and assessing impact of issues
- Support system upgrades and enhancements
- Author, review and approve SOPs, protocols, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards
- Creates system reports per end user and management requests
- The System Administrator will apply analytical, communication, and problem-solving skills to help identify, communicate, and resolve issues
- 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.
- Strong knowledge of systems and networking software, hardware, and networking protocols.
- Previous LIMS implementation and administration experience.
- Prior experience reviewing and analyzing GMP data for analytical methods.
- Familiarity with Empower and SoftMax pro software is a plus.
- Prior experience in analytics for biopharmaceutical/biologics is preferred.
- Experience in participation in development, validation, transfer, testing with chromatographic (HPLC), biophysical methods, and immunologic methods (ELISA).
- 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).
Preferred Experience, Special Skills, Knowledge:
- Ability to effectively prioritize and deliver on tight timelines.
- Communicates effectively with supervisors, colleagues and subordinates
- Excellent written and verbal communication skills
- Experience with use of Excel or comparable software solutions for management of QC, Manufacturing data
- Accuracy and attention to detail
- Time management skills, ability to elevate relevant issues to project lead
- Excellent cross-functional team participation 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
- A plus, experience with JMP, iStability, and/or Minitab or other software for statistical analysis of analytical data
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.
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.
This job is no longer accepting applications
See open jobs at Aimmune Therapeutics.See open jobs similar to "Senior Manager, Quality Control Clinical Programs and LIMS Administration" Foresite Capital LP.