- Novo Nordisk (Fremont, CA)
- …heart failure. Are you ready to make a difference? The Position The Senior Manager - CMC Manufacturing Supply Chain will be responsible for developing ... Drug Product, both internally and externally with CMO's. The Senior Manager - CMC Manufacturing Supply Chain will need to navigate a broad stakeholder… more
- BeiGene (Emeryville, 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
- Pfizer (Andover, MA)
- …personnel to expedite approval of pending registrations and respond to queries. As a Senior Manager , your advanced knowledge of the principles and concepts in ... **What You Will Achieve** You will help Pfizer develop and implement chemistry, manufacturing and controls ( CMC ) regulatory strategies for small and/or large… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... This position comes with 4 direct reports (Dir, Sr Manager , Manager & Associate III). The Sr...manufacturing , and labeling. The Sr Director, Regulatory Affairs CMC is also responsible for the oversight of maintaining… more
- Regeneron Pharmaceuticals (Troy, NY)
- …to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, Manufacturing , and Controls ( ... might include the following: + Preparing and reviewing global CMC documents and sections for a variety of commercial...Manager : Requires 7+ years of relevant experience + Senior Manager : Requires 8+ years of relevant… more
- Merck (Rahway, NJ)
- … Manufacturing Division functional areas in designing and analyzing CMC -related studies, and in coordinating other statistical activities for drug/vaccine ... methodologies and tools to enable the discovery, development, regulatory approval, manufacturing , and marketing of medical drugs and vaccines for the benefit… more
- Novo Nordisk (Boulder, CO)
- …change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady ... The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its...of his/her duties, the Manager / Senior Manager should seek to actively improve existing manufacturing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports ... supply of Gilead's clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** **Key Responsibilities** Manager , Global External Manufacturing Oral-Solid Dosage (OSD) works to ... verbal and written communication skills, including ability to interact effectively with senior management at Gilead and contract manufacturing organizations. +… more
- University of Colorado (Aurora, CO)
- QA Senior Manager - 33670 University Staff...+ Serve as the QA point of contact in CMC and Process Development and direct QA functional areas ... Anschutz Medical Campus** **Department: Gates Biomanufacturing Center** **Job Title: QA Senior Manager ** **Position #: 00803572 - Requisition #:33670** **Job… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... cross-functional teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is responsible for leading and… more
- RTX Corporation (Forest, MS)
- …United States of America Location: MS301: 19859 Highway 80, Forest 19859 Highway 80 CMC Forest, Forest, MS, 39074 USA Position Role Type: Onsite At Raytheon, the ... create a safer, more secure world. The Program Operations Manager is accountable for all Operations scope associated with...partner with a cross-functional program team and the applicable manufacturing sites (factories) to develop and execute a … more
- Taiho Oncology (Princeton, NJ)
- …team at Taiho Oncology where innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role in ... Sr. Manager , Analytical Development Princeton, NJ, USA Req #362...serving as analytical lead for assigned projects with the CMC team. Liaises with CMOs to ensure methods are… more
- BD (Becton, Dickinson and Company) (Vernon Hills, IL)
- …Complaint Handling Unit (DCHU), Sterility Assurance, etc.), as well as R&D, Manufacturing , Sales, Marketing, Operations, and Finance. The Senior Quality Engineer ... **Job Description Summary** The Senior Quality Engineer is responsible for supporting Design...of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs, is responsible for the development and ... primarily to marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and… more
- Novo Nordisk (Boulder, CO)
- …solving skills, creativity, and initiative Please note we are open to hiring at senior Manager title commensurate with experience We commit to an inclusive ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- RTX Corporation (Mckinney, TX)
- …on the role of Sr Manager in support of our McKinney Consolidated Manufacturing Center ( CMC ) in North Texas. Candidate will be responsible for leading the ... a strategic plan, leading a team of engineers, and working with stakeholders/ Senior Factory Leaders to ensure the successful implementation of these technologies.… more
- Hubbell Power Systems (Greenville, AL)
- …Location: Greenville, AL, US, 36037-2435 Company: Hubbell Incorporated Job Overview The Plant Manager for CMC Greenville, AL, is responsible for overseeing the ... Plant Manager - Greenville, AL Apply now " Date: May 25, 2024...daily operations of manufacturing plants and the employees. In this role the plant manager ,… more
- Insight Global (Boston, MA)
- …A large life sciences company in a the Boston area is hiring a Project Manager to support their Manufacturing org. The Project Manager is responsible ... status reporting, risk management, and issue escalation to stakeholders and senior management. Additionally, they work on departmental organizational projects and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the strategic business relationship with multiple contract development and manufacturing organizations (CDMOs). This includes ownership of the strategy, selection, ... performance (monthly/annually) + Serve as an escalation point for manufacturing operations team members for recurrent or chronic performance...issues of high complexity + Communicates issues to line manager and project teams in a timely manner +… more