- 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
- 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 ... product complaints arise during product lifecycle for the assigned project . . Provide CMC regulatory review for...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… 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
- 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
- Leidos (Houston, TX)
- …stream-lined use of Systems Engineering tools and techniques. * Advise the customer, Project Manager , and Lead Systems Engineer on Systems Engineering strategies ... & Integrator** to work on NASA's Cargo Mission Contract ( CMC ). This position is located on-site at the Johnson...Mobility Program (EHP). This role works closely with the Project Lead Systems Engineer and project systems… more
- J&J Family of Companies (Titusville, NJ)
- …safety (PSTS) areas of expertise + Drive strategic decisions and achieve key deliverables CMC team, PSTS team, and project management team (PMT), based upon ... Pharmaceutical Development Program Manager - 2406180821W **Description** Janssen Research & Development,...responsibility to deliver program outcomes: + Provide insights into project timelines and resources, exhibit proactive risk and issue… more
- Merck (Boston, MA)
- …and maintain patient continuity of supply. Working independently, the Clinical Supplies Project Manager (CSPM) designs strategic and operational plans for all ... teams and the operational/executional arms within the business. Clinical Supplies Project Managers (CSPMs) are responsible for the translation of global clinical… 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
- Merck (Boston, MA)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... as well as supply chain documentation to support critical CMC activities. + Support the collection of clinical supply...Skills:** + At least 6 years of experience in project management. + At least 3 years of experience… 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
- 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
- Stantec (Denver, CO)
- …and industry experience to consistently produce project deliverables that meet project requirements and project manager and client expectations. Work ... HVAC, piping and plumbing. **Your Key Responsibilities** + With direction from a project manager and/or Professional Engineer, designs mechanical systems for the… more
- Merck (North Wales, PA)
- …Office (PMO), and Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director, Project Manager , is a core member of Early Drug ... **Job Description** Global Project and Alliance Management (GPAM) sits in the...from diverse disciplines (eg, clinical, regulatory, market access, manufacturing, CMC , commercial, and other areas) as applicable to the… more
- CSL Behring (King Of Prussia, PA)
- …the biotechnology or pharmaceutical industry** **At least 4 years as a project manager leading and managing complex, cross-functional drug development ... our King of Prussia PA office. It is a Hybrid role. The Associate Director, R&D Project Planning Capability Lead, is a member of CSL R&D's Project and Portfolio… more