Senior Manager, Commercial Quality Control

Position: Senior Manager, Commercial Quality Control
Reports to: Director, Commercial Quality Control
Location: U.S. Remote

Summary:
The Senior Manager, Commercial Quality Control, will be a key member of the team and will support all activities associated with commercial quality control of Zenpep® and Viokace® products conducted at the Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs). This role will provide input into global commercial testing strategy and manage the QC quality systems, key performance indicators (KPIs) and processes to ensure robust, quality, and efficient delivery of product testing. This position will be responsible for biologics pharmaceutical products quality control of raw materials and IPCs, release & stability testing, in addition, to method transfers, conducting investigations, audits, methods lifecycle, and regulatory submissions/responses.  The candidate will work in a virtual quality control environment and will manage established, remote global testing facilities through audits, establishing KPIs, and data review processes. The candidate will work closely with Manufacturing Services, Supply Chain, Quality Assurance, Regulatory Affairs, and Project Management to ensure timely testing and release of materials intended for commercial Zenpep® and Viokace® products in alignment with corporate goals. The individual will manage and respond to regulatory commitments, as well as other regulatory interactions and will contribute to regulatory filings (BLA, IND, IMPD). The candidate will provide input into analytical activities in Analytical Development for these products to ensure test methodologies/optimizations are aligned with commercial product release and regulatory compliance/commitments.

Specific Responsibilities:

• Manage activities associated with Quality Control release and stability testing of commercial pharmaceutical products, Zenpep ® and Viokace®, at CTLs/CMOs.
• Responsible for regulatory filings, such as post-approval commitments, as well as other regulatory communications.
• Drive continued improvements in quality systems (procedures and systems) to improve quality assurance compliance and regulatory and other requirements (cGMP, ICH) with all applicable compendial (e.g., USP, NF, EP) monographs.
• Lead technology transfer to new/existing CMOs/CTLs.
• Responsible for the review and approval of Quality Control SOPs, product specifications, method optimization/ validation /verification protocols, reports and technical reports.
• Lead investigations conducted at CMOs/CTLs including review of out-of-specification (OOS) and out- of-trend (OOT) testing results, deviations.
• Identify and address technical and validation gaps in analytical methods and QC testing for commercial products. Collaborate with CMOs/CTLs to devise and implement method lifecycle improvements.
• Oversee analytical transfers between CMOs/CTLs. These may include HPLC, ELISA, and other immunochemical and electrophoretic methods.
• Develop and manage relationships with CTLs to effective delivery of all testing data, for analytical activities (method lifecycle & transfer) , as well as established KPIs for continuous improvement.
• Work collaboratively with Manufacturing Services, Supply Chain, Quality Assurance, Regulatory Affairs, and Project Management to ensure timely progress and completion of cross-functional projects.

Qualifications / Requirements:

• B.S./M.S. in Chemistry, Biochemistry, Analytical Chemistry or a related field
• Minimum of 8-10+ years of relevant professional experience including a combination of Quality Control and Analytical Development.
• Prior experience managing internal/external Quality Control testing at a CTL or CMO is required Prior experience managing Analytical Development is preferred
• Experience with analytical method development and validation, as well as product characterization using multiple analytical techniques is required

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.
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