- ThermoFisher Scientific (Middleton, WI)
- …to accuracy and quality to deliver groundbreaking innovations! **Discover Impactful Work:** The Data Reviewer performs review of a variety of routine ... of PCR and sequencing strongly preferred + Previous experience with formal data review in GMP Lab strongly preferred + Previous experience with method validation… more
- Lilly (Indianapolis, IN)
- … and Peptide APIs at external manufacturing facilities globally. The Sr. Director - Quality - Small Molecule API EM is the Site Quality Leader for the Small ... for all quality activities related to the oversight of Small Molecule APIs for commercial products. They...complaints are investigated and resolved. + Ensuring appropriate stability data is available to support storage and retest or… more
- BeOne Medicines (San Mateo, CA)
- …join our growing in-house IP legal team to serve as a leader of our Small Molecule IP team and support BeOne Medicines R&D, business development, and ... team in the US and China primarily focused on small molecule portfolio to build and maintain...in discovery, research, manufacturing, and development on patent, regulatory data exclusivity, trademark, and other intellectual property issues. *… more
- Lilly (Lebanon, IN)
- …with central TSMS teams and other manufacturing sites to ensure robust molecule stewardship, seamless transfer of API from pre-commercial to commercial stages, and ... define and implement control strategies for Lilly Lebanon processes. + Author, review , or approve standard operating procedures related to TS/MS activities. … more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Head of Global Regulatory Affairs, CMC Small Molecule **Location:** Morristown, NJ **About the job** Join the engine of Sanofi's mission - where ... positive and favorable relationships with Agencies. + Oversees the preparation review and approval of Regulatory CMC submissions (including writing as applicable),… more
- Lilly (Houston, TX)
- …Principal Process Engineer provides technical leadership for production operations in small molecule or peptide manufacturing. Key responsibilities include ... in core engineering practices for oligonucleotide API supply + Promote data -driven decision-making using statistical methods and first principles + Support and… more
- Lilly (Lebanon, IN)
- …. Minimum BS in Engineering and experience in Automation Engineering, preferably in Small Molecule API manufacturing and 10+ years working experience in ... and commissioning . Process control work implementation and coordination . Review and monitor financial performance; commit to meeting targets . Develop… more
- Lilly (Indianapolis, IN)
- …process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and ... resolve/escalate. + Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its… more
- Gilead Sciences, Inc. (Foster City, CA)
- …is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides strategic leadership and oversee ... QC team supporting both clinical and commercial programs for biologics and small molecule sectors. This individual is committed to personnel interactions… more
- Takeda Pharmaceuticals (Boston, MA)
- …(GMSci) is the subject matter expert and primary technical contact for Takeda's small molecule API manufacturing for synthetic drug substance across the product ... strengthen manufacturing robustness and supply continuity. As needed, you will represent Small Molecule Drug Substance in forums with partners including… more
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