The Principal Scientist will be a member of the Analytical Development group and will support activities associated with method development, validation, and characterization of assets within the expanding Aimmune clinical and commercial pipeline including oral immunotherapies (OITs), monoclonal antibodies (mAbs), pancreatic enzyme replacement therapies (PERTs), and microbiome. The candidate will have demonstrated expertise in the characterization of biological molecules (e.g., LC-MS, peptide mapping, bioassay), design and execution of comparability studies. In addition, the incumbent will develop and validate of quantitative mass spectrometric based methods for protein content, purity, or other attributes. Background in bioassay development and experience with characterization of solid dosage formulations. This role will function as an analytical project lead for one or more clinical programs with all aspects from test methods, characterization, stability, and specification development. This role will provide direction for the future growth of the characterization responsible for multiple programs. The successful candidate will support discovery, clinical and commercial applications and work closely with team members in Analytical Development and Quality Control, as well as other functions including Manufacturing, CMC team, Project Development and Regulatory, to ensure the timely development, validation, testing and release of materials to be used to support clinical activities. Prior experience with release/stability method development and validation of protein products, characterization of biologics, authoring of CMC sections of regulatory submissions (responses, INDs), plus the demonstrated ability to work effectively to timelines in a virtual environment (i.e., external CROs, CMOs, CTLs, etc.) are requirements for the position.
- Role of analytical SME for biologics characterization and comparability studies.
- Manage the development of analytical methods and subsequent validations with CTLs and CMOs.
- Oversee quality control and stability testing of the product at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs).
- Provide content and author for sections related to analytical methods, product specifications, and product stability in INDs, IMPDs, and later NDAs, BLAs, and other regulatory submissions.
- Coordinate analytical methods transfers (particularly enzyme activity assays and in-vitro dissolution methods) to and between CMOs and CTLs
- Contribute (as analytical SME) to investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
- Work collaboratively with manufacturing/supply chain, quality assurance and CMC project management to ensure timely availability of lot release and stability data and to ensure adequate planning for stability supplies.
- Note: Essential Duties and Responsibilities include the previous. Other duties may be assigned
Preferred Experience, Special Skills, Knowledge:
- B.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 12 years relevant experience in analytical development and/or quality control in pharmaceutical setting. Prefer M.S. (with +12 years experience) or Ph.D. (with +10 years experience) with industry-related experience. Title will depend on experience level of the successful candidate.
- Extensive mass spectrometric experience with characterization of biologics, as well as development of qualitative/quantitative methods for release testing is required.
- Familiarity with bioassays (ELISAS and other binding assays) is a plus
- Demonstrated experience as analytical projects lead for all analytical activities from methods, specification development, characterization, to stability studies is required.
- Prior experience of managing direct reports (research associate to scientists) is highly preferred.
- Experience in the development and validation of enzyme activity assays (e.g., spectrophotometric, fluorometric, chemiluminescent, etc.) for oral biologics (e.g., OITs, solid dosage forms).
- Knowledge and hands-on experience with GxP dissolution method development and testing.
- Familiarity with United States Pharmacopeia (USP) [General Chapter 〈711〉], European Pharmacopeia (EP), US FDA, and SUPAC guidelines for solid dose products including biopharmaceutical classification system, and IVIVC/IVIVR concepts.
- Ability to design and perform in-vitro comparative dissolution experiments in both traditional pH media and biorelevant media (i.e., physiological based dissolution test).
- Familiarity with physiological dissolution test (PBDT) models a plus.
- Support formulation development in screening of immediate/sustained release solid dosage forms.
- Support creation/execution of in-vitro dissolution packages for purposes of formulation bridging during clinical development and in support of commercial lifecycle management.
- Experience managing/working with quality control release/stability testing at a CTL or CMO is preferred
- Experience in characterization, method development, validation, and transfer of analytical methods for biologics using various techniques such as HPLC, CE, and mass spectrometry (MS)
- Experience in safety tests such as bioburden and host cell proteins is a plus
- Experience with development of various type of methods for testing product attributes: assay, purity, identification, impurities, safety tests (e.g. bioburden)
- Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to quality testing of pharmaceutical products
- Ability to effectively prioritize and deliver on tight timelines.
- Excellent written and verbal communication skills.
- Expertise in use of Excel or comparable software solutions for management of stability data
- Accuracy and attention to detail
- Excellent cross-functional team participation skills
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 and food digestion & absorption. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions. 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.