- Merck & Co. (Rahway, NJ)
- Job DescriptionThis is a hands-on pipeline project facing opportunity to be the primary day-to-day RCMCS lead to develop study design (DOE), statistical ... with and mentor junior statisticians. In addition to pipeline project responsibilities, there will be an abundance of opportunity...written communication skills to be able to function and lead effectively in a team environment. Must be able… more
- Aequor (Thousand Oaks, CA)
- …and education to expanding current job responsibilities. is searching for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement ... product, and device expertise Nice to have tools: Planisware, MS Project , Smartsheet discovers, develops and delivers innovative human therapeutics. A biotechnology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …that fit the site's needs. The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project delivery.Leads ... Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support… more
- Merck & Co. (Rahway, NJ)
- …reputation through conference participation.Represent BPR&D as a upstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise, ... medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process… more
- Insmed Incorporated (NJ)
- …and Clinical Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and ... and external partnersServe as clinical supply representative on cross-functional project and clinical strategy teams; translate protocol design into demand/supply… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities for our cell and gene ... ability to work cross-functionally in a fast-paced biotech environmentKey Responsibilities Lead and oversee all toxicology strategy and execution for preclinical… more
- Organon & Co. (Plymouth Meeting, PA)
- …regulations and?guidance, and?Organon procedures.? The Associate Principal Scientist will lead the?preparation and submission of CMC dossiers?for life-cycle ... but are not limited to:? **Responsibilities** + Serve as the? CMC Product Lead ?for assigned products and be?accountable...Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of … more
- Organon & Co. (Plymouth Meeting, PA)
- …science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project management and other partner groups as part ... **Job Description** **The** **Position** The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES end users to define change ... Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC , and IT. This individual will support the MES...reliably gauge task effort and plan work to meet project timelinesWork closely with the MES and MSAT organization… more
- CSL Behring (King Of Prussia, PA)
- …- In-depth knowledge in the drug development processes for pharmaceuticals (eg project management, CMC , non-clinical, clinical, Regulatory Affairs). - Experience ... innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building...week. You will hold work closely with the CDT Lead and other Clinical Representatives in performing delegated tasks… more
- WuXi AppTec (Natick, MA)
- …Technical Marketing Specialist- CMC (San Diego, CA) - Analyze pharmaceutical project and technical requirements for CMC projects for business development; ... and conferences, applying knowledge of chemical engineering, biochemistry, pharmaceutical project management, Chemistry, Manufacturing, and Controls ( CMC )… more
- Organon & Co. (Jersey City, NJ)
- …regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle ... are not limited to: **Responsibilities** + Serve as the CMC Product Lead for assigned products and...Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of … more
- CSL Behring (King Of Prussia, PA)
- …is accelerating innovation to deliver greater impact for patients. With a project -led structure and a focus on collaboration, we're building a future-ready team ... Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate...(eg, GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk… more
- Parexel (Trenton, NJ)
- **Join Parexel as a Post-Approval Regulatory Strategy Lead !** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... love to connect. We are seeking a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will… more
- Arup (Los Angeles, CA)
- …edge systems that will meet challenges in decarbonization and resiliency. Our aim is to lead our clients into a sustainable future but we will deliver this in an ... the delivery of coordinated and code-compliant designs. + Participate in project meetings and coordinate with architects, engineers, and consultants. + Prepare… more
- BeOne Medicines (San Mateo, CA)
- …across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology teams. While Regulatory Operations ... risks and support leadership decision-making. **Audit & Inspection Support** + Lead planning, preparation, and execution of internal audits and mock inspections.… more
- BeOne Medicines (Emeryville, CA)
- As Director of R&D Data Enablement / Data Products, you will lead the strategy and execution of building and scaling R&D data foundations and data products that ... By collaborating with stakeholders across Research, Clinical, Safety, Regulatory, Portfolio & Project Management and other R&D functions, you will ensure data is… more
- Kelly Services (South San Francisco, CA)
- …and agility. **Responsibilities** + ** Lead & Empower:** Steer multiple small molecule CMC projects as the project management lead , championing clear ... Kelly(R) Science & Clinical is seeking a CMC Project Manager for a one-year contract opportunity with a leading biopharmaceutical company in South San Francisco,… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager** **Location: Cambridge, MA (Hybrid)** **About the role:** As ... a CMC Project Manager, you will provide ...a CMC Project Manager, you will provide project management...management of one or more small molecule products as co- lead with the CMC Lead ;… more
- AbbVie (North Chicago, IL)
- …to interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval ... impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage...CMC Regulatory and Process R&D. + Partner with CMC Regulatory to assist CMC project… more
