Associate Director, Quality Control Stability Program Management
The Quality Control candidate will be a part of the Analytical Development and Quality Control Team with a key focus on supporting commercial and clinical drug substance and drug product activities for all Aimmune products. The candidate will lead and coordinate all QC related activities associated with the management of the Aimmune stability program. Additionally, the candidate will also support the analysis, review, and trending of release and stability data, support new and on-going stability programs, regulatory filings (IND, BLA and MAA), author SOPs, and participate in investigations and raw data audits from CTLs. Prior experience with commercial quality control release/stability testing/manufacturing development of pharmaceutical products is required. The candidate must have extensive knowledge of FDA, ICH and EU stability regulatory requirements. The individual should have the ability to work effectively in a virtual analytical development, quality control, and manufacturing environment.
- Coordinate and lead QC related activities associated with clinical and commercial stability studies for all Aimmune products.
- Extensive knowledge of the regulatory requirements for clinical and commercial stability studies.
- Responsible for compiling and reporting metrics associated with the stability program, and communicate internally and to contract testing lab (CTLs).
- Author, review and approve stability protocols, reports and specifications.
- Responsible for shelf-life determination and extensions.
- Create a Certificate of Analysis (CoA) for lot release and stability data.
- Maintain and report metrics and KPIs related to the stability program, CoA process and CTL performance.
- Work with CTLs to ensure stability schedules are aligned with protocols, required raw data is uploaded timely and appropriately, and request corrections and communicate timelines specific to the stability program to the CTLs
- Analyze and review quality stability data for Aimmune’s pharmaceutical products at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs)
- Identify OOS and OOT results and own subsequent investigations and follow up
- Create and maintain stability master data in an electronic system (iStability, LIMS, etc)
- Participate in the implementation of the stability module for new LIMS software
- Lead process improvement activities associated with the stability program.
- Develop and manage trackers for all stability studies
- Interface with various internal departments (QA and manufacturing) to address and resolve questions to enable timely delivery of stability reports
- Prepare and review batch analysis, stability tables, and trend charts 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), change control records, test methods ™, method validation/verification protocols, reports and technical reports, and manufacturing process development reports.
- Prepare and arrange QC meeting minutes, Sample/critical reagent shipment forms/memos, and other routine QC documentation as needed
- Additional responsibilities may be assigned, as required, or in consideration of the candidate’s expertise and skills
Qualifications / Requirements:
- B.S. or advanced degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 7-10 years relevant experience in pharmaceutical development in Quality Control, Analytical Development, or Manufacturing function
- At least 3 years of experience as a people manager.
- Prior experience with managing commercial and clinical stability programs
- Prior experience reviewing and analyzing GMP data for analytical methods
- Familiarity with Empower and Softmaxpro software is a plus
- Prior experience in analytics for biopharmaceutical/biologics is preferred
- 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)
Preferred Experience, Special Skills, Knowledge:
- Ability to effectively prioritize and deliver on tight timelines.
- Excellent written and verbal communication skills
- Experience with use of Excel or comparable software solutions for management of QC, Manufacturing data
- Accuracy and attention to detail
- Time management skills, ability to elevate relevant issues to project lead
- Excellent cross-functional team participation skills
- Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment
- A plus, experience with LIMS,JMP, iStability, and/or Minitab or other software for statistical analysis of analytical data
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. 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.