- 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
- 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
- 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)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Manager , Global External Manufacturing , Small Molecule Drug Substance** **KEY ... RESPONSIBILITIES** Manager , Global External Manufacturing , Small Molecule Drug Substance (DS) works to ensure uninterrupted supply of Gilead's clinical and… 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …mail and email; and manage managers calendar's (including Pharmaceutical Development & Manufacturing Leadership Team, CMC Regulatory Affairs Leadership Team OOO ... with minimal guidance. + Leads the planning, logistics, and scheduling for CMC Regulatory Affairs Leadership Team meetings and any other similar leadership meeting… more
- Merck (North Wales, PA)
- …in the Research & Development organization at our company. **Position Description/Summary** The Senior Specialist, Project Manager is a core member of Early Drug ... and tactical input from diverse disciplines (eg, clinical, regulatory, market access, manufacturing , CMC , commercial, and other areas) as applicable to the… 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: Apr 26, 2024...daily operations of manufacturing plants and the employees. In this role the plant manager ,… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by ... in the Analytical Development and Operations (ADO) organization reports to the Senior Director of Analytical Development (AD). AD is primarily responsible for… more
- Integra LifeSciences (Plainsboro, NJ)
- …to work onsite. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing . **SUPERVISION EXERCISED** Directly supervises ... responsible for the skin and medical packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …well as staff from quality, clinical compliance, regulatory, formulations, and IOPS ( CMC , external manufacturing , stability). **A typical day might include the ... The **Sr Manager , Clinical Drug Supply & Logistics** is responsible...Responsible for working within established timelines of investigational product manufacturing , labeling, release, distribution and return/destruction, and/or helping to… more