- Regeneron Pharmaceuticals (Troy, NY)
- The Manager , CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple clinical programs ... and/or submissions. As a Manager , CMC Regulatory Sciences , a typical...to inquiries from regulatory agencies on the content of CMC documents + Collaborates with project teams… more
- J&J Family of Companies (Raritan, NJ)
- Manager Global CMC Regulatory Affairs - 2406185933W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Manager , CMC Regulatory ... according to scientific and risk-based principles. + Participates as regulatory lead on CMC /VCM teams and represents CMC RA by providing regulatory expertise to… more
- Lilly (Indianapolis, IN)
- …with CMC and device team members, program teams and functional leads. + Provide CMC Project Management for both internal and external CMC development and ... better for people around the world. **Associate Director** **; CMC , Device Development Program Manager ** **Functional Area:...+ Create, maintain, and articulate for various audiences detailed CMC and device project plans to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …support their development + May serve as direct/matrix manager of RAV CMC staff, depending on project . Responsible for prioritization of workload and ... as required. Participate in and/or lead agency meetings on CMC topics. + Ensure project team colleagues, line management, and key stakeholders are apprised… more
- Novo Nordisk (Boulder, CO)
- …we are driving change. Are you ready to make a difference? The Position Experienced Project Manager that can manage complex projects within budget, on time, & ... with 1:1s, roadblock resolution, risk reporting, & overall first level of project guidance. Relationships Reports into Director, CMC Program Development.… more
- 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 and ... complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines...Product, both internally and externally with CMO's. The Senior Manager - CMC Manufacturing Supply Chain will… more
- GE Aerospace (Evendale, OH)
- …data science, manufacturing, quality, and program management. You will serve as a project manager and technical mentor for a small team of mechanical ... This role is within the Commercial Ceramic Matrix Composite ( CMC ) Mechanical Design team in GE Aerospace's Engineering Division....of own team to arrive at decisions. + Manage project plans and action plans for executing on component… more
- Frontier Medicines (Boston, MA)
- 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
- GE Aerospace (Evendale, OH)
- **Job Description Summary** The Sub-Section Manager demonstrates accountability for functional, business, and broad company objectives. In this role you will ... will manage a team that provides mechanical and lifing analysis for CMC components on commercial applications. You will support business objectives across multiple… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of key project timelines and CMC milestones + Acts in a project manager capacity to ensure:, change controls, , deviations or other issues, lab ... needed **Essential Project Management Activities:** + Represents quality assurance in CMC Teams and/or PDM Sub teams. + Leads a sub-team of Quality professionals… more
- Teva Pharmaceuticals (West Chester, PA)
- …and updating CMC sections of submissions for assigned products. As Sr. Manager CMC Regulatory Affairs you will also be responsible for identifying and ... Project Team (CPT), Clinical Development Team (CDT), and CMC Team to ensure successful execution of the global...assigned projects. **How you'll spend your day** As Sr. Manager , CMC Regulatory Affairs you will be… more
- Kelly Services (Plainsboro, NJ)
- Kelly Services is currently seeking for a **Quality Project Manager - HYBRID** for one of our top clients in **Plainsboro, NJ.** **JOB TITLE: ** Quality ... Project Manager - HYBRID **INDUSTRY:** Medical Device...on the quality of products, systems, and operations at CMC . This includes coordination with corporate and divisional quality,… more
- AECOM (Portland, OR)
- …equitable future. Join us and let's get started. **Job Description** **AECOM** is seeking a ** Project Manager I** to be based in **Portland, Oregon** . The job ... responsibilities of the ** Project Manager **...PDS, POR, OPR documents, acquisition support, and BD, D-B-B, CMc procurement); design phase management (design and constructability reviews,… more
- AECOM (Portland, OR)
- …better world. Join us. **Job Description** AECOM is seeking a qualified **Construction Project Manager ** to provide on-site PM/CM support for various Federal and ... throughout the **Portland Oregon** metro area. The responsibilities of the **Construction Project Manager ** include: + Managing project (s) involving the… more
- Stantec (San Francisco, CA)
- Mechanical Engineer - Project Manager - ( 2400017O ) **Description** Stantec Buildings is on a mission to become the world's leading integrated design practice. ... to consistently produce project deliverables that meet project requirements, project manager and...Strong knowledge of applicable codes and standards, including CBC, CMC , NFPA, and ASHRAE, as well as LEED, green… more
- Bausch Health (Petaluma, CA)
- …needed as well as consumer products. + In concert with the Core Team, the Project Manager will develop, maintain, and drive the project timelines milestones ... + Should have good working knowledge of all areas of development - including CMC , non-clinical, clinical, project management and regulatory functions + Will be… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager , Analytical Development Princeton, NJ, USA Req #362 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role...serving as analytical lead for assigned projects with the CMC team. Liaises with CMOs to ensure methods are… more
- AbbVie (Madison, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / ... with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in the development… more
- Merck (Rahway, NJ)
- …& Development organization at our company. **Position Description/Summary** The Senior Specialist, Project Manager is a core member of Early Drug Development ... simple projects independently or moderate-complexity assignments in conjunction with a partner project manager . Projects could span any therapeutic areas in… more
- Stantec (San Diego, CA)
- …and industry experience to consistently produce project deliverables that meet project requirements and project manager and client expectations. Work ... plumbing. **Your Key Responsibilities** + With direction from a project manager and/or Professional Engineer, designs mechanical...design. + Knowledge of applicable codes and standards, including CMC , CPC, CFC, CBC, NFPA, and ASHRAE, as well… more