- Amgen (Thousand Oaks, CA)
- …worldwide. It's time for a career you can be proud of. Senior Project Manager - CMC Integration Project Management **Live** **What you will do** ... and understanding Process Development activities by developing and maintaining project timeline for Pivotal and Lifecycle Management projects within Amgen's… more
- BeiGene (Hopewell, NJ)
- **General Description:** This is an individual position for CMC and Project management of initial start of facility and tech transfer that requires advanced ... the ability to develop rapport internal and external to CMC . This role will directly support Project ...to CMC . This role will directly support Project Management, Technology Transfer, Regulatory Filings/Inspections. This position plays… more
- BeiGene (Emeryville, CA)
- …and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality ... throughout product life cycle. Escalate the critical issues to senior management timely. . Lead or contribute to development...product complaints arise during product lifecycle for the assigned project . . Provide CMC regulatory review for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives. **Responsibilities:** +… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. 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
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Program Manager /Associate Director, CMC Portfolio Management will ... to enable cross-functional teams to achieve key asset milestones. The Senior Program Manager /Associate Director will provide timeline/scenario planning and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + **Regulatory Knowledge:** Demonstrates expert knowledge of US/EU… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to secure and ... Functions of the Job:** + Serve as the regulatory CMC representative on project teams. Provides ...organization. **Significant Contacts** + Interacts with BeiGene employees and senior management. + Interacts with external business partners and… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...cultivating vendor relationships + Supervising third-party activities and delivering project updates with recommendations Traits we believe make a… more
- MTA (New York, NY)
- …Specialist SALARY RANGE : $54,518- $90,863 DEPT/DIV : HR Center Of Excellence SUPERVISOR : Senior Manager , CMC LOCATION : 333 West 34th Street, New York, ... CMC Broadband Specialist Job ID: 8479 Business Unit:...operating procedures and training documents as needed + Support project activities including requirements gathering, functional design & configuration,… more
- Integra LifeSciences (Plainsboro, NJ)
- …implementing procedures, and remediation projects. The candidate must be a senior -level professional/team player with advanced knowledge and experience who thrives ... Microbiology, and Sterility Assurance department and working with the ** CMC Plainsboro, NJ** Integra manufacturing site. Qualified candidates must possess… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team AD representative or team lead). + Represent functional area on CMC project teams by communicating activities from designated functional area to ... or externally. + Identify and plan broader technical objectives ( project and scientific related) with input from manager...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** ** Senior Manager , Formulation Development** will be responsible for leading drug ... other manufacturing activities at CMOs. + Work within the CMC group and with internal and external project...veteran status, disability or any other legally protected status. Senior Manager , Formulation Development: Base Salary Range… more
- BeiGene (San Mateo, CA)
- …into the exciting arena of alliance management and business development. The Senior Manager , Alliance Management Operations candidate will provide essential ... transparency, and organizational readiness for BeiGene's expanding alliance portfolio. The Senior Manager , Alliance Management Operations candidate will remain… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Clinical Supply Chain** . The Senior ... supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external… more
- Ascendis Pharma (Palo Alto, CA)
- …for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and clinical) collaboration with other project team members. ... all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Manager : Strategic Sourcing and Supplier Management, Devices** Gilead ... with headquarters in Foster City, California. **KEY RESPONSIBILITIES:** The Senior Manager , Strategic Sourcing & Supplier Management,...issues of high complexity. + Communicates issues to line manager and project teams in a timely… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …lives while developing professionally to achieve your own career goals. **Title:** Senior Manager / Associate Director of Stability **Position Summary:** The ... art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of...Stability Associate Director/ Senior Manager is responsible for managing the… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a ** Senior Manager /Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve ... stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory, CMC , and project management to ensure completion of… more
- Novo Nordisk (Watertown, MA)
- …+ Identify key stake holders and work collaboratively with cross-functional CMC , commercial, quality, regulatory, project management, legal, sourcing, supply ... will be part of a team based in Watertown, MA and report to the manager of the drug product outsourcing group. The team collaborates with other Boston-based teams on… more