- WuXi AppTec (Philadelphia, PA)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for a ** Manager / Senior Manager , CMC Project Management.** This position ... will be responsible for managing DS and DP projects within STA. The position will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team, and business development team. The… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... **Job Description** + Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances,… more
- Sumitomo Pharma (Harrisburg, PA)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Clinical Supply Chain** . The Senior ... supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external… more
- Sumitomo Pharma (Harrisburg, PA)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …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, aggregate reports, NDAs… more
- WuXi AppTec (Philadelphia, PA)
- …oligo and peptide discovery business along with cultivating these relationships into CMC for IND enable studies with our manufacturing (CDMO) business. The candidate ... will work within the North America discovery business development team to pursue new business leads in addition to follow ups on critical issues and aid in resolving customer inquiries. **Responsibilities** + Hunting and Prospecting for oligo and peptide new… more
- Merck (West Point, PA)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (West Point, PA)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (West Point, PA)
- …Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (West Point, PA)
- …Global Human Health (GHH) brand/ franchise commercial goals. The Biologics VCM Product Manager (PM) works under direction of the VCM Product Leader supporting the ... product supply strategies for one or more Biologics products. The VCM Product Manager will be responsible for supporting supply chain design, global filing and… more