- Aequor (Thousand Oaks, CA)
- …education to expanding current job responsibilities. is searching for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement in ... on our main corporate campus in Thousand Oaks, CA. The Sr. Project Manager (PM) will be responsible for integrating Process Development (PD) activities by developing… more
- Merck & Co. (Rahway, NJ)
- …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 & Co. (Rahway, NJ)
- …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 & Co. (Rahway, NJ)
- …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
- BeOne Medicines (Emeryville, CA)
- …**:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving program-level compliance ... guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology teams. While Regulatory Operations manages… more
- CSL Behring (Waltham, MA)
- …developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Vaccines? The job is in our ... delivery teams. May lead discussion at Global Regulatory Forum (GRF) or with senior management on projects. -Lead GRA project deliverables (eg, Core Briefing Books,… more
- Integra LifeSciences (Plainsboro, NJ)
- …through Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend ... Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- Danaher Corporation (Fargo, ND)
- …(https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Sr. Program Manager is responsible for fostering and maintaining a ... This individual collaborates closely with the Commercial Key Account Manager and serves as the primary point of contact...This position reports to the Director of Drug Product CMC and is part of the Drug Product Program… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Genentech (San Diego, CA)
- …or Senior Principal** **Requirements for Principal** **External Collaborations Site Manager :** + You possess a Bachelor's degree in Engineering or Life Sciences ... success in managing multiple organizational interfaces and stakeholders. **Requirements for Senior Principal** **External Collaborations Site Manager :** + You… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy across the… more
- ThermoFisher Scientific (Wilmington, NC)
- …to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical operational and ... may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; eg process… more
- AbbVie (North Chicago, IL)
- …campaigns and manage process orders and shipping. + Collaborates with the materials manager , program manager , and/or team lead to set expectations for ... written and oral). Key Stakeholders: Project team members from development, analytical, CMC and QA Coordinators from other Operations/sites Supply Chain and tech… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Senior Scientist, MSAT **Location** : Framingham, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the ... from infectious diseases and bring hope to patients and their families. The Senior Scientist will be responsible for developing and executing bioassays for various… more
- US Tech Solutions (Thousand Oaks, CA)
- …experience in the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable + Ability to foster collaboration and ... work effectively on cross-functional teams + Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization + Critical thinking and problem-solving skills + Apply standard Project Management tools,… more
- ThermoFisher Scientific (Morrisville, NC)
- …experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC , Regulatory or related compliance experience with at least 5 ... years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections. **Knowledge, Skills, Abilities:** Must be an expert Quality compliance auditor. Experience with elements… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …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
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location: ... within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director, Product Management Team Lead** will lead a team of… more
