- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Manager , CMC Operations is responsible for independently managing technical ... transfer documents for Lilly and CMOs + Support the CMC team in ensuring that internal and external manufacturing...deployed products + Be a key resource for manufacturing operations and analytical troubleshooting at CMOs + Demonstrate a… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager , Clinical Operations will also coordinate reporting and review of CRO ... **Job** **Summary** The Manager , Clinical Operations works closely with...manage monitoring oversight activities including managing Clinical Monitoring Consultants ( CMC ) contracted to perform monitoring oversight duties as well… more
- CSL Behring (King Of Prussia, PA)
- …Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk ... and decision making. Ensures bi-directional communication with stationed region commercial operations and GRA. With support, engaging with health authority (HA) in… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by ... and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations , QC and Clinical Supplies Operations , and other Otsuka Companies,… more
- Eurofins US Network (Lancaster, PA)
- …in pharmaceutical sciences, analytical chemistry, or biologics. + Experience in GMP lab operations , especially in CMC testing. + Proven ability to manage complex ... and products. **Job Description** **Role Overview** The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing Good Manufacturing… more
- Kelly Services (Malvern, PA)
- …solution provider and business unit of Kelly Services, Inc., is currently seeking a Content Manager for a 12 month + engagement at one of our Global clients in ... phase changes of API clinical materials per Chemistry, Manufacturing, & Controls ( CMC ) timelines. **New Product Introduction (NPI) Tech Transfers** + Accountable for… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations , etc.) to develop ... global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements,… more
- Parexel (Harrisburg, PA)
- Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large, dedicated client team to drive impactful labeling operations ... markets. In this role, you will oversee end-to-end labeling operations across multiple markets, for Foundational (US, EU, CH,...* Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in… more
- Sanofi Group (Swiftwater, PA)
- …diseases and bring hope to patients and their families. The Biostatistics Manager of the TED (Translational and Early Development) team supports Vaccine R&D ... support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work in close collaboration… more
- Intertek (York, PA)
- …Tier3 support for escalations and project work. Reporting to the North Amer IT Manager . HERE'S WHAT YOU'LL DO ON THE JOB: + Maintain all field office filesystem ... and procedures. + Coordinate data recovery requirements with field office operations personnel. + Document and maintain field office specific disaster recovery… more