Senior Manager, Clinical Programs (Remote)
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. 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 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.
Coordinate and lead QC related activities at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs) associated with Clinical programs.
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.
Audit and review analytical data such as HPLC, ELISA and protein content from contract testing laboratories
Prepare and review batch analysis and trend charts for internal reports and regulatory submissions and requests for information (IND, IMPD, RFI).
Analyzes, trends, and reviews quality control release testing and method performance data for pharmaceutical products at CTLs and/or (CMOs).
Supports activities for Pre-Licensing Inspection (PLI) readiness as well as CTLs and/or CRO/CMO compliance audits as needed.
Prepare and review manufacturing process development studies for internal reports 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.
Participates in continuous improvements of quality systems (procedures and systems) to improve organization effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
Prepare and arrange QC meeting minutes, Sample/critical reagent shipment forms/memos, and other routine QC documentations as needed
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
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)