- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Early-Stage Biologics Development, CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Early-stage Biologics Development, CMC will be… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …requirements for CMC and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance and perspective ... Provide CMC regulatory strategy input and expertise in the...marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka's products are developed/maintained in… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Sciences La Verne Engineering Project Management Office (PMO) is seeking a ** Senior Manager , Project Management New Product Line Manufacturing - ... Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory/ CMC , EHS, Finance, IT, and Engineering. ** Project ...or MBA. + 3+ years successfully serving as a project manager . + Proven experience in managing… more
- Integra LifeSciences (Plainsboro, NJ)
- …innovate new treatment pathways to advance patient outcomes and set new standards of care. The ** Senior Project Manager ** is a key member of the value stream ... leadership team for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value...goals and ensure successful execution. Provide regular updates to senior management on project status, performance metrics,… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... for patients suffering from immunological diseases. Position Summary: The Senior Manager , Process Development, Downstream will be...CMC team and other key functions such as project management, QA and Regulatory, the ideal candidate must… more
- Sumitomo Pharma (Frankfort, KY)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Regulatory Affairs** . The Senior Manager ... (HA) information requests. This position represents GRA on less complex project related meetings and provides regulatory input as appropriate. This position… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description AbbVie is seeking an Associate Project Manager to drive the execution and oversight of projects ... early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director, and Delivery System Senior Leadership. Your role… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …(E&L) knowledge and material evaluation experience to join our team as a Senior Manager to contribute toward the advancement of innovative T-cell therapy ... cancer treatment at Kite's Santa Monica, CA facility. The Senior Manager will lead Kite's cell therapy...work closely with teams from Process Development, Analytical, Validation, CMC and Regulatory Affairs to evaluate and monitor the… more
- Merck (Rahway, NJ)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
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