Analytical Development and Quality Control, QC Contractor/Consultant
The Analytical Development & QC professional will be an experienced contractor / consultant contributing to the analytical method development team. The candidate will support design and development of tests, studies, procedures, and specifications used for control of Aimmune’s APIs and drug products. Tests will include cGMP quality control tests and characterization tests to understand important attributes of Aimmunes products. Studies will include ICH studies, product characterization studies, and method characterization / validation studies.
The candidate will be subject matter expert (SME) for development projects, lead planning efforts, and provide detailed interpretation of test results. Working closely with Aimmune’s regulatory team, the candidate will submit critical studies and documentation to the FDA and international regulatory agencies. She/he will oversee QC and stability tests for analytical methods which have been validated and transitioned to QC for regular use.
Prior experience with method development of proteins, QC, stability, IND submissions, BLA or NDA submissions, plus the demonstrated ability to work effectively in a virtual environment are important for success in the position.
- Identify, oversee, and collaborate with CTLs and CMOs who analyze food allergens to determine their potency / allergenicity.
- Lead the development and validation of analytical methods with CTL’s and CMO’s for the potency, purity, and content of Aimmune’s products. Assays may include HPLC, ELISA, and other methods.
- Use testing information to support manufacturing of oral immunotherapy (allergy desensitization) products. Interpret characterization, product release, and stability data.
- Participate in establishment / revision of drug substance and drug product specifications for IND, IMPD, and BLA submissions using statistical analysis and other approaches.
- Act as the subject matter expert for investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
- Author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA).
Education and/or experience:
- Advanced degree (Ph.D. or MS) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 6 years relevant experience in a pharmaceutical cGMP environment, or BS with at least 10 years of experience.
- Excellent written and verbal communication skills. Technical writing for IND and regulatory submissions is desirable.
- Expertise in use of Excel or comparable software solutions for management and analysis of data. Experience with JMP and/or Minitab is desirable.
- Accuracy and attention to detail.
- Excellent cross-functional team participation skills.
- Outstanding problem solving abilities.
- Ability to effectively prioritize and deliver on tight timelines.
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics is a clinical-stage biopharmaceutical company located in Brisbane, California, in the biotechnology hub south of San Francisco. The company is developing desensitization treatments for food allergies initiated an international Phase 3 trial for its lead product, for the treatment of peanut allergy, in early 2016. Phase 3 data is anticipated in the first quarter of 2018. Aimmune hopes to file a BLA application in 2018. For more information, please visit www.aimmune.com.
Aimmune Therapeutics offers a competitive compensation and benefits package.
Aimmune Therapeutics is an Equal Opportunity Employer.
Qualified candidates should forward a resume and cover letter, including a statement of interest, availability, and experience.
Principals only; no recruiters please.