Pharmaceutical & BioScience Society, PBSS

Position:
The Associate Director, 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.

Employer:
Aimmune Therapeutics

Description:

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 support investigation 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/Experience:

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
Previous managerial experience is required
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
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, verbal communication and presentation 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

Location: Brisbane, California

Contact: jtalesfore@aimmune.com

Post Date: 9/24/2019 12:14:03 PM