Scientist Analytical Development-Huntsville, AL
Candidates should have experience in the development/ implementation of new/rugged analytical methods using state-of-the-art analytical technologies. Candidates should have working knowledge of cGMP practices and ICH guidelines pertaining to analytical activities. A broad knowledge of analytical techniques such as HPLC, ELISA, SDS-PAGE, CE, isolation/purification of impurities/degradants using standard/specialized analytical systems and excellent oral/written communication skills is a plus. The individual will have to evaluate and interpret complex data and test results (e.g., stability studies, product characterization studies). To qualify, you must have a Ph.D. in Chemistry or in Pharmaceutical Sciences preferably with a core expertise/experience in Analytical Chemistry/Separation Sciences/Instrument Analysis area with 2 years (or greater) of relevant Laboratory experience in the pharmaceutical or biopharmaceutical industry. Experience with biologics and CMC regulatory documents is a plus.
This laboratory leadership position provides direction to conduct a broad spectrum of analytical activities such as development and validation of new analytical methods for development products (pre-clinical through commercialization) for in-process, release and stability analysis, as well as transfer the methods to Contract Manufacturing organizations (CMOs). The position includes the responsibility to monitor/evaluate completion of project related tasks, generate all CMC documents to support US/EU health authority submissions, modify/propose new specifications, write/coordinate regulatory updates/filing activities for new methods/ specifications, and work closely with CMO laboratories to evaluate /test analytical methods for development products. The position supports all laboratory activities to comply with cGMP requirements, maintenance of project-related reference standards/reference materials, and train/mentor laboratory staff on new analytical technology which would enhance problem solving capability, technical expertise and throughput. The position has the opportunity to make major contributions to scientific literature, conferences and/or understanding of company processes. This position contributes to and supports the company’s pipeline development efforts to create high value therapeutics to address unmet medical needs.
Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are highly desired. Previous management skills are a plus. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills.
A PhD in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 2 years work experience in a research and/or development environment is required.
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