Stability Specialist job in Brattleboro
|Company Type:||Certified B Corporation|
|Industry:||Consumer Packaged Goods Manufacturing|
|Job Type:||Science & R&D|
|Impact Area:||Quality of Life|
|Company Name:|| New Chapter|
|State / Province:||Vermont (VT)|
|Zip / Postal Code:||05301|
New Chapter, Inc. is seeking a Stability Specialist for our Brattleboro, Vermont location. Develop and execute cGMP stability programs for products. Develop and modify testing methods, including ORAC value measurement and HPLC RP/NP analysis, for dietary supplements and natural products. Work with internal resources, as well as external contract storage facilities and analytical laboratories, to develop plans and execute quality and compliant global stability studies related to vitamins and marker compounds in dietary supplements and herbal formulations following FDA regulations. Coordinate and monitor stability programs for New Chapter dietary supplements and herbal formulations following FDA regulations and ICH guidelines. Write formal stability study protocols. Work with Quality Assurance, Regulatory Affairs, and Science & Innovation teams on new product development and in-market product stability logistics and quality. Conduct quality control projects, including shelf-life studies, potential supplier approval, SOP revision, and R&D sample qualification. Author Standard Operating Procedures (SOP) for dietary supplements.
Qualified applicants will have a bachelor’s degree in Chemistry, Biology, Life Science or a related field plus one (1) year of experience in a working scientific laboratory. One (1) year of experience must include: Developing, modifying, and executing analytical test methods for dietary supplements and natural products, via application of High Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC) techniques; Conducting instrument Installation Qualification and Operational Qualification (IQ/OQ) and overseeing instrument calibrations; Documenting sample analyses to Good Manufacturing Practices (GMP) standards; Developing, modifying, and executing in vitro test methods for dietary supplements and natural products, including ORAC value measurement; Developing and executing GMP stability programs to establish shelf-life for dietary supplements, including writing stability study protocols, managing stability pulls, generating stability data, and writing stability reports; and Conducting quality control projects, including qualification of new R&D botanical extracts and potential new supplier qualifications.
Please submit your resume, indicating Requisition Code LA-ZC,to New Chapter, Inc., Attn: Lori Aldrich at 90 Technology Drive Brattleboro, Vermont 05301. EOE M/F/D/V.