Scientist / Sr. Scientist, Analytical Chemistry
The scientist/senior scientist will be responsible for small molecule analytical drug substance and drug product-related activities to assist with formulation and chemical process development including assisting with both preclinical and clinical stage method development, method transfer, method validation activities, method troubleshooting, analytical data review for release and stability and stability trending. The essential duties and responsibilities will include:
- Development of various analytical methods to support drug substance and drug product development at various clinical stages as per ICH guidelines.
- Management of analytical chemistry activities both internally and at contract laboratories including analytical method development & validation, release testing and stability activities
- Preparation and/or review of written documents including technical reports, validation protocol & report, stability protocol & report, specification, and regulatory filings, etc.
- Analytical characterization of drug substance and drug product batches in support of early discovery
- Collaboration with department and company colleagues to execute assignments
- Presentation of results in department and company meetings
- Serving as analytical lead in multidisciplinary project teams and/or sub-team meetings within the company or with CROs
- Performing hands-on experiments, documentation, and data review and providing significant contributions and oversight to contract labs for protocols, deviations, investigations, CAPA's, reports, stability data, trending, shelf-life/retest dating, using where applicable, current regression analysis practices and other relevant statistical techniques.
- Authoring analytical sections of CMC submissions in support of regulatory filings.
- Ph.D or MS/BS in Organic/Analytical Chemistry, Pharmaceutical Sciences or related discipline
- Relevant experience in the biotech/pharmaceutical industry.
- Extensive hands-on experience with HPLC, UPLC, GC, MS, dissolution method, etc.
- Working knowledge of cGMP, FDA, USP, Ph Eur, and ICH guidelines and regulations
- Deep understanding of analytical development, and a strong ability to trouble-shoot technical problems and to generate new experimental proposals built on existing methods or techniques, or published literature methods.
- Experience with CMO/CRO oversight
- Highly independent, detail oriented, and self-motivated and integrates well within a team
- Good organizational skills with ability to work in a high paced team environment to meet deadlines and prioritize work on multiple projects
- Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
- Excellent oral and written communications skills.
- Good safety practices at all times, including appropriate use of protective equipment