- ThermoFisher Scientific (Boston, MA)
- …ensure accuracy and completeness of information presented in analytical documents and regulatory filings. Assist with comment resolution if needed + Support internal ... Material Science, Immunology, Biology, Molecular Biology or similar + **Sr. Scientist :** Previous experience that provides the knowledge, skills, and abilities to… more
- Astellas Pharma (Northbrook, IL)
- …data review, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance. + Provide technical expertise and guidance over the assay life ... cycle. + Contribute to regulatory submission documentation ie, INDs, IBs, NDAs/BLAs + Ability...Extensive experience in chromatography assays of small molecules and biologics + Exposure to work experience in assay validations… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Analytics Associate Scientist II** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The...in Kansas City, MO is hiring an Analytics Associate Scientist II. Under general supervision, the Associate Scientist… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …comprehensive safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers. Job Summary: ... The Clinical Data Scientist position interacts with many FDA stakeholders across several...(eg, adequate and well-controlled studies) + Familiarity with FDA regulatory process. + Working experience at FDA. + Experience… more
- Merck (Rahway, NJ)
- …Scientist position available at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with ... methodology, we collaborate to discover the next medical breakthrough. The Biologics Analytical Research & Development department of our Company's Research &… more
- Teva Pharmaceuticals (West Chester, PA)
- …manufacturing processes, and technology transfer to GMP sites. We are hiring a Senior Scientist at West Chester, PA, to drive process development, ... Sr Scientist Date: Aug 30, 2025 Location: West Chester,...products to benefit patients worldwide. Our multidisciplinary team advances biologics and biosimilars. Within Teva, Biologics CMC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …team, ** Biologics Pre-Pivotal Formulation and Process Development** , as a ** Senior ** **As** **sociate Scientist ** . The successful candidate will contribute ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …help create more tomorrows. **Job Description** We are seeking a highly motivated ** Senior Associate Scientist ** to join our Process Impurities Development team ... biology techniques, along with a working knowledge of ICH, USP, and EU regulatory guidelines for analytical method development. You will play a critical role in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …expert in toxicology across therapeutic areas. The Highly Distinguished Research Scientist needs to have deep understanding about what is technically feasible, ... study or research support for both small molecules and biologics . * Contribute to project plans that will influence...Research to Development transitions of nominated drug candidates to Regulatory Toxicology and R&D Drug Development Teams. * Serve… more
- Capgemini (Boston, MA)
- …the following functional areas: Research & Development (R&D), Manufacturing, Clinical, Regulatory , Laboratory or Quality. + Bachelor's degree - Engineering or ... of Life Sciences trends including Medical Devices, Cell and Gene Therapies, Biologics , and Gen AI. + Experience Selling Life Science Manufacturing Engineering… more