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Associate Director, Analytical Development & Quality Control

The Associate Director, Analytical Development & Quality Control will be a key member of the analytical team and he/she will support activities associated with quality control activities of Aimmune's APIs and drug products conducted at CTL/CMO.  This position will be responsible for biologics quality control release/stability testing of pharmaceutical products, method validations, transfers, and conducting investigations.  This role will be engaged and responsible for development of quality systems procedures and systems for product testing.   Candidate will work in virtual quality control testing environment and will management remote testing facilities.  The candidate will work closely with Manufacturing/Supply Chain, Quality Assurance, and CMC Project Management to ensure timely testing and release of materials to be used in Aimmune clinical trials. The individual will be also contributing to regulatory filings (BLA, IND), as well as, regulatory responses.  The candidate will contribute to commercial quality control planning activities.  The candidate will also participate and influence analytical activities in Analytical Development for early and late stage clinical programs. ESSENTIAL DUTIES:  Oversee all activities associated with quality control and stability testing of Aimmune's pharmaceutical products at Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs) Contributing to regulatory filings (BLA, IND), as well as, regulatory responses. Support continued improvements in quality systems (procedures and systems) to improve organization effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH). Support activities for Pre-Licensing Inspection (PLI) readiness Write, review and approve Analytical Development and Quality Control SOPs, specifications, method validation and verification protocols and reports and technical reports Lead and supportinvestigation conducted at CMO/CTL and review and approve 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 in preparation for product commercialization. Work with CTLs and CMOs to devise and implement improvements in analytical methods Coordinate and oversee analytical methods transfers to and between CMOs and CTLs. These methods may include HPLC, ELISA, and other methods Ensure compliance of Aimmune analytical testing activities with applicable compendia (e.g., USP, NF, EP) and regulatory guidance documents Manage CLT for effective delivery of all testing data, analytical activities (method development, validation, transfer), and analytical data for manufacturing studies Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data, as well, as progress and completion of cross-functional projects.    QUALIFICATIONS/REQUIREMENTS Education and/orexperience: Advanced degree (M.S., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry, or a related field 10+ years relevant professional experience including 8 years in a combination of QC and AD is required. Previous managerial experience is required as well. Prior experience managing QC testing and AD at a CTL or CMO Hands-on experience with analytical method development and validation, as well as, product characterization using biophysical, mass spectrometric, or immune methods Demonstrated experience with HPLC, ELISA-based methods and protein analysis strongly preferred Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to quality testing of pharmaceutical products Ability to travel up to 10% of the time Special skills/knowledge: Ability to effectively prioritize and deliver high-quality results on tight timelines Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment Excellent written and verbal communication skills Accuracy and attention to detail Excellent cross-functional team participation skills Outstanding problem solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment Ability to recognize & implement potential of new technologies to meet Aimmune product testing requirements
Salary Range: NA
Minimum Qualification
11 - 15 years

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