- 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. (Columbus, OH)
- …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 (Columbus, OH)
- …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
- 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
- Merck (Rahway, NJ)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs...preferred. + At least 8 years of experience in project management. + At least 5 years of experience… more
- Vera Therapeutics (Brisbane, CA)
- …in the US and globally to support development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * ... Title: Senior Manager , Clinical Regulatory Location: Brisbane,...regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams * Evaluate proposed clinical protocol changes for… more
- Merck (West Point, PA)
- …Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- RTX Corporation (East Hartford, CT)
- …owns the execution of strategy and operational direction of the Ceramics Matrix Composite ( CMC ) CIPT, by leading a 45-50 team consisting of a Deputy, IPT Leaders, ... CIPT Leader is accountable for the overall advancement of CMC Material systems and relevant HSE Part designs and...(BOAS, HPT Vanes, etc) + Collaborating with the Technology Manager , Carlsbad COE and MPE on program technologies needs… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** **The Senior Manager ,** **GPV Compliance & Business Management will support the** **leads of Global PV** **Audit & Inspection readiness** ... limited to the planning and** **conducting** **readiness activities/training.** **As the** **Sr. Manager for audits and inspection** **, support the GPV Audit &… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of global ... of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC , etc.) to contribute to global regulatory plans, address global regulatory… more
- Vera Therapeutics (Brisbane, CA)
- …with other functional areas including Clinical Operations, Biometrics, Pharmacology and CMC . * Project manage early-stage development activities including within ... meetings (pre-IND, type B meetings). * Report regularly on project status, risks, and outcomes to senior ...and staffing companies) are prohibited from contacting our hiring manager (s), executive team members, or employees. We require that… more
- Takeda Pharmaceuticals (Boston, MA)
- …into issues and develops contingency plans; communicates timely and proactively project -related issues to senior executive management and manages issues ... and empower you to shine? Join us as a Senior Director, Global Program Leader (GPL) in our Cambridge...through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &… more
- POWER Engineers (Eau Claire, WI)
- **PTE Senior Field P&C Engineer** Location **Milwaukee** Secondary Locations **Appleton, Eau Claire, Green Bay, Madison** Job Code **18136** \# of openings **1** ... please send us your resume. This position reports to the Midwest Region Department Manager or Area Lead. Under the guidance of an experienced Field Engineer or… more
- Bausch Health (Bridgewater, NJ)
- …development team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in ... your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for… more
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