Principal / Senior Analytical Scientist (Drug Substance, NCE, API) – RTP, NC Pharma – Direct Hire
Our client, an RTP-based pharmaceutical firm undergoing tremendous change and expansion, is actively recruiting for a skilled and knowledgeable Analytical Chemist for a key role providing analytical support for manufacturing processes of New Chemical Entities and Active Pharmaceutical Ingredients.
This is a dynamic and challenging setting. This role will focus on supporting projects in development. Responsibilities will include development, validation, and transfer of analytical methods to support regulatory filing of drug substance manufacturing processes. As well as, conducting hands-on work in the lab to develop transferable methods, resolve development issues and support regulatory submissions.
This is a lab based role and we seek a candidate who enjoys the bench. The ideal candidate will have advanced degree in Chemistry with 8-10+ years of experience. Experience working in the oncology or severe disease space is a plus.
This is a Direct Hire position and the Company will offer generous compensation package to attract and retain a quality candidate.
Role will involve:
- Evaluating, developing, validating and documenting analytical results and methods
- Critically review, tabulate, and interpret analytical and spectroscopic data
- Develop, design, and conduct experiments with little oversight
- Draft/review protocols, reports, CoAs, laboratory notebooks, SOPs, etc.
- Contribute to selection, oversight, and management of CROs.
- Interact with cross-functional teams to maintain project deliverables and timelines.
Targeted candidate will offer a Ph.D. in chemistry or related field with 5+ years of experience, MS with 10+ years of experience, BS with 15+ years of experience in the pharmaceutical industry. Substantial experience working under GMP and regulatory requirements pertaining to the development and validation of analytical methods for drug substances, intermediates, starting materials, process impurities and degradation products. Experience authoring regulatory filings for NCEs is a strong plus.
Expertise with the following techniques and instrumentation will be critical:
- Analytical techniques, including HPLC assay and impurities, HSGC-FID, KF, UV/Vis, CAD, FTIR, LC-MS, etc
- Executing spectroscopic techniques used for identification of impurities and degradation products
- Resolving OOS/OOT issues.
- Ability to guide, direct, and manage contract manufacturing facilities and testing facilities.
This is a dynamic, empowered, collaborative and mission-driven setting. In addition to requirements noted above, we seek a smart, insightful, self-directed and extremely competent scientist. We seek a flexible and resourceful candidate who will thrive in an emerging company environment.