Associate Director/Director, Commercial Quality Control
Position: Associate Director/Director, Commercial Quality Control
Reports to: Sr. Director, Quality Control and Analytical Development
The Associate Director, Commercial Quality Control will be a key member of the analytical team and he/she will support all activities associated with commercial quality control of Palforzia and other products conducted at CTLs/CMOs. This position will be responsible for biologics pharmaceutical products quality control of raw materials, in-process, and release/stability in addition to method transfers, conducting investigations, audits, and regulatory inspections support. This role will be engaged and lead the development/maintenance of QC quality systems procedures and in effect use of data management systems (LIMS).
Candidate will work in a virtual quality control environment and will manage remote global testing facilities through selection, audits, establishing KPI. 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 clinical trials or commercial products. The individual will also contribute to regulatory filings (BLA, IND, IMPD), as well as, other regulatory communications. The candidate will contribute to expanding QC infrastructure (personnel and systems) supporting multiple commercial products and clinical pipeline. The candidate will also participate and influence analytical activities in Analytical Development for early and late stage clinical programs.
- 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, IMPD), as well as, regulatory communications.
- Support continued improvements in quality systems (procedures and systems) to improve organization effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH) with applicable compendia (e.g., USP, NF, EP) monographs
- Support technology transfer to new CMOs/CTLs.
- Review and approve Analytical Development and Quality Control SOPs, specifications, method validation and verification protocols and reports and technical reports.
- Lead/support investigations 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 for products. Work with CTLs and CMOs to devise and implement method lifecycle improvements.
- Coordinate and oversee analytical methods transfers between CMOs/CTLs. These methods may include HPLC, ELISA, and other methods
- Manage CLTs to effective delivery of all testing data, for analytical activities (method lifecycle, transfer) and for manufacturing studies
- Work collaboratively with manufacturing services, supply chain, quality assurance, regulatory affairs, and project management to ensure timely availability of all analytical data, reports, as well, as progress and completion of cross-functional projects.
Qualifications / Requirements:
- Advanced degree (M.S., Ph.D.) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 7-10 + years of relevant professional experience including 8 years in a combination of Quality Control and Analytical Development. Previous managerial experience of multiple reports is required.
- Prior experience managing internal/external QC testing and AD at a CTL or CMO
- Experience with analytical method development and validation, as well as, product characterization using biophysical, mass spectrometric, or immune methods is required
- Demonstrated experience with HPLC, ELISA-based methods and protein analysis strongly preferred
- Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Global Regulatory Guidance Documents as they relate to quality testing of pharmaceutical products
- Ability to travel up to 10% of the time
Preferred Experience, 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
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc. is a biopharmaceutical company that aspires to become the global leader in developing curative therapies and solutions for patients with food allergies. With a mission to improve the lives of people with food allergies, Aimmune is developing and commercializing oral treatments for potentially life-threatening food allergies. The Company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. 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.