- Bristol Myers Squibb (Summit, NJ)
- …Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS- CMC senior manager will assess Manufacturing Change Controls for global impact ... to address external questions regarding drug products. **Position Summary / Objective** The Senior Manager , GRS- CMC is responsible for content development,… 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
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 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
- Actalent (Lexington, MA)
- Responsibilities: The Contract Manager / Senior Manager - CMC QC will: * Support the external contract organization activities to fulfill the GMP QC ... testing needs * Provide internal support to CMC Operations to support the development, manufacture, and material release, including method… 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
- GE Aerospace (Evendale, OH)
- **Job Description Summary** The Senior Manufacturing Engineer demonstrates accountability for functional, business, and broad company objectives. In this role ... Producibility. Responsible for organization and updates of MRL/Producibility process for CMC manufacturing including running the reviews, publishing notes… 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
- Intra-Cellular Therapies, Inc (New York, NY)
- …CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** ** Senior Manager , Formulation Development** will be responsible for leading drug product ... Manufacturing and Supply Chain group of the ITCI CMC team. Responsibilities: + Lead and support activities for...veteran status, disability or any other legally protected status. Senior Manager , Formulation Development: Base Salary Range… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …a Sr. Manager , Quality Assurance, in the Pharmaceutical Development and Manufacturing (PDM) organization. The Sr. Manager provides quality and compliance ... CMC team(s). + Interact with contract manufacturers/labs, internal manufacturing , and Analytical Operations to resolve quality issues. + Provide oversight… 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 (Marlborough, MA)
- …with the Secondary Strategic Business Unit (SSBU) vision, and works with Consolidated Manufacturing Centers ( CMC ) to deliver Program results and will directly ... with the Secondary Strategic Business Unit (SSBU) vision, and works with Consolidated Manufacturing Centers ( CMC ) to deliver Program results. What You Will Do:… 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
- 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
- Amazon (Bellevue, WA)
- Description We are seeking a Senior Manager for our functional safety engineering development team. In this role, it will be your job to help drive engineering ... yet rapidly expanding team. This position reports directly to the Sr Manager of Regulatory Compliance. Key job responsibilities * Applying IEC industrial standards… more
- Integra LifeSciences (Plainsboro, NJ)
- … manufacturing , laboratory, support, and non-GMP spaces of the Collagen Manufacturing Center ( CMC ). Projects range from construction, equipment installation, ... and making headway to help improve outcomes. The **Project Engineering Manager ** is responsible for the technical and administrative leadership of facilities,… 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