- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …with ICH regulatory requirements and all local country regulatory requirementsStrong project management skills and strong interpersonal skills to handle ... documents for regulatory submissions and associated messagingWork closely with regulatory CMC lead and overall development team to insure overall regulatory strategy… more
- System One (Warren, NJ)
- …support project objectives. + Develop and maintain detailed CMC project plans, including resource allocation, risk management , and timeline tracking. + ... CMC activities. + The ideal candidate will have a strong background in project management and CMC support, with the ability to lead cross-functional teams… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …priorities simultaneously. preferred - 4 or More Years Extensive experience in project management , process, product, and/or analytical development activities and ... CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project ...to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess … more
- AbbVie (North Chicago, IL)
- …objectives or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline ... CMC development experience through IND and/or NDA/MAA/BLA. Experience leading multiple CMC project teams through IND and NDA/MAA/BLA preferred. + Technical… more
- AbbVie (North Chicago, IL)
- …Clinical, Regulatory, Operations, Quality, Preclinical Safety and Commercial Organizations. Apprises CMC Management of strategies, plans and risks through ... areas on the ADTAST serving as spokesperson for the CMC project team and ensures information flow...develops agendas, issues highlights, apprise risks and plans with CMC Management , conduct periodic reviews, to ensure… more
- Insight Global (Rahway, NJ)
- …process documentation, including workflows, use cases, and data models. * Support project management activities, including task tracking, status reporting, and ... Proven experience with digital transformation projects, including process automation and data management . Proficiency in project management and business… more
- GE Aerospace (Evendale, OH)
- …processing, materials behavior, and/or chemical production + Effective team building and project management ability + Graduate Engineering degree preferred + ... will be a member of the Ceramic Matrix Composite ( CMC ) and Environmental Barrier Coating (EBC) materials and processing...whose mission is to advance state of the art CMC 's and EBC's and enable CMC technologies… more
- Regeneron Pharmaceuticals (Troy, NY)
- …to reach consensus. Strong communication skills, both oral and written. + Strong project management leadership skills essential + Good understanding of the drug ... The Director of CMC Industry and Regulatory Intelligence is responsible for...Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance excellence by ensuring Regeneron IOPS… more
- GE Aerospace (Evendale, OH)
- …problems. Ability to document, plan, market, and execute programs. + Established project management skills. + Collaborative, team oriented. + Humble: respectful, ... **Job Description Summary** The CMC Lead Manufacturing Engineer will lead the strategic...CMC Lead Manufacturing Engineer will lead the strategic management of process development, improvements, stability, and growth across… more
- GE Aerospace (Evendale, OH)
- …+ Proven ability to coordinate multiple projects simultaneously with demonstrated project management expertise + Effective problem-solving, analytical skills, ... design and analysis, materials engineering, data science, manufacturing, quality, and program management . You will serve as a project manager and technical… more
- GE Aerospace (Evendale, OH)
- …materials behavior, textiles and/or chemical production + Effective team building and project management ability + Graduate Engineering degree + Strong oral ... will be a member of the Ceramic Matrix Composite ( CMC ) and Environmental Barrier Coating (EBC) materials and processing...whose mission is to advance state of the art CMC 's and EBC's and enable CMC technologies… more
- Regeneron Pharmaceuticals (Troy, NY)
- …or equivalent combination of education and experience; Bachelor's degree preferred. + Project management experience preferred. + Strong experience creating and ... trackers for regulatory submissions for assigned programs. + Keeps management and others informed on progress of CMC... management and others informed on progress of CMC -RS deliverables for assigned programs. + Department support: +… more
- WuXi AppTec (Philadelphia, PA)
- …* Ability to manage independently the complicated key account projects, and possess strong project management skills for the analytical aspects of the project ... milestones, overall progress, project scope, and indicators. Demonstrate proficiency in project risk management . * Demonstrate comprehensive control at the … more
- WuXi AppTec (Philadelphia, PA)
- …requirements meet the regulatory requirement of the target filing country. * Possess good project management skills for the analytical aspects of the project ... overall progress, project scope, and indicators. Demonstrate proficiency in project risk management . * Author, review and/or approve relevant technical… more
- Frontier Medicines (South San Francisco, CA)
- …years of experience in small molecule drug substances and drug products + Project Management experience considered advantageous + Proven ability to work ... Medicines on an exciting journey as our newest Principal Scientist/Associate Director, CMC Development located at our South San Francisco office. As a crucial… more
- UTMB Health (Huntsville, TX)
- …writing skills and ability to write specifications. + Good organizational and project management skills. + Demonstrate the ability to proactively assist ... Acquisition Specialist - CMC - Huntsville **Huntsville, Texas, United States** **New**...FUNCTIONS_** **:** + Assists Customers in procurement planning and project coordination by providing budgetary/cost analysis, sourcing, technical &… more
- Atlantic Health System (Pompton Plains, NJ)
- …Functions: + Oversee ordering of supplies from storeroom and/ or purchasing via PM as necessary, taking note of surplus and depletion of supplies. Check daily ... in a timely manner. + Stocking/ inventory: in conjunction with material management maintains adequate par levels for all supplies, and all associated functions.… more
- Merck (North Wales, PA)
- …realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient ... influence and mastery of project management to take on challenging assignments...from diverse disciplines (eg, clinical, regulatory, market access, manufacturing, CMC , commercial, and other areas) as applicable to the… 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 ... theories, deliverables, and models for others to use. + Project management skills; ability to manage one's...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …including project onboarding, discussions, email chains, and documentation. + CMC Response Management : Maintain and organize responses related to ... with raw material qualification processes. + Technical Proficiency: Proficiency in using project management tools like Smartsheet and document management … more
