- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Novo Nordisk Inc. (Boulder, CO)
- …and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing ... 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …Control Teams ( CMC ) to enable R&D Development Team objectives/deliverables. **Position:** Senior Manager , CMC Project Operations **Location:** New ... appropriate allocation of DS and API materials for non-clinical use. + The CMC Project Manager may co-lead and/or contribute to Product Development portfolio… 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
- Kelly Services (Vancouver, WA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you're passionate ... **Workplace:** Onsite in Vancouver, WA **Salary:** $95,000-130,000 **Overview** Drive CMC development, scale-up, cGMP manufacturing, and quality control for our… 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 Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to ... 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
- 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
- Merck (Boston, MA)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… 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
- Integra LifeSciences (Plainsboro, NJ)
- …4,000 of us are challenging what's possible and making headway to help improve outcomes. The ** Senior Project Manager ** is a key member of the value stream ... leadership team for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value...goals and ensure successful execution. Provide regular updates to senior management on project status, performance metrics,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Manager , Project Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and ... for the planning and execution of multiple small molecules and/or biologics CMC programs. The Sr. Project Manager will partner with PDM Product Strategy Team… more
- GE Aerospace (Evendale, OH)
- …your opportunity to thrive in a cross-functional, dynamic environment. **Job Description** The Senior CMC Laboratory Operations Manager is responsible for ... for a lab focused on cutting-edge ceramic matrix composite ( CMC ) technology. In this critical role, you will be...of 5 years of experience in a program or project leadership role within an engineering environment. **Desired Characteristics**… more
- Merck (West Point, PA)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs...preferred. + At least 8 years of experience in project management. + At least 5 years of experience… more
- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... development of regulatory strategy, providing regulatory advice and oversight to project teams and supporting regulatory submissions and department activities. This… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply ... but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA),Regulatory Affairs and Sourcing departments. +… more
- Bausch Health (Petaluma, CA)
- …with accuracy and in accordance with established procedures + Effectively communicates with Manager , team members, and Senior Management + Organized and able to ... impact. DESCRIPTION OF JOB: Creates and executes extensive analytical and CMC development plans for pharmaceutical active ingredients, excipients, oral and topical… more
- CBRE (Los Angeles, CA)
- …needs, including: Furniture, Equipment, Signage, Decor, Props, and Supplies + Works with Senior Marketing Manager to complete the following: Signage Plans and ... Events Operations Manager Job ID 183608 Posted 16-Oct-2024 Service line...findings to management. + Lead the execution of all CMC self-produced trade shows from start to finish by… more
- Stantec (Denver, CO)
- Senior Mechanical Design Engineer - ( 240003J3 )...to consistently produce project deliverables that meet project requirements, project manager and ... and design your place with Stantec. **Your Opportunity** The Senior Mechanical Building Designer draws on strong buildings engineering...within project budgets and schedules to help project manager meet project financial… more
- System One (Florham Park, NJ)
- …for process improvements. In addition to these standard publishing requirements, the Senior Regulatory Operations Associate will bring project management skills ... Senior Regulatory Operations Associate Contractor (Publishing) Must be...implement Regulatory Operations' initiatives by attending and participating in Project Teams if deemed appropriate by manager .… more
