- 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
- Merck & Co. (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
- Axelon Services Corporation (Seattle, WA)
- …support project objectives. - Develop and maintain detailed CMC project plans, including resource allocation, risk management , and timeline tracking. - ... with alliance management Job Description The Technical Project Manager ( PM ) will be a key...The ideal candidate will have a strong background in project management and CMC support,… more
- Axelon Services Corporation (Warren, NJ)
- …Warren NJ Top Skills: - 5+ years' experience in bio tech/life sciences project management ; cell Therapy experience preferred. - Bachelor's degree in STEM/Life ... Sciences-related discipline. - Project management qualification preferred - Proficiency with...analytical method development & transfer. Job Description The Technical Project Manager ( PM ) will be a key… more
- Merck & Co. (Rahway, NJ)
- …follow up studies post transfer activities (RY or WP as needed).Apply project management tools to support validation and transfer activities for ... vaccines, adjuvants, and biologics such as monoclonal antibodies, small molecules. Project management experience tracking, supporting and communicating timely… more
- Dexian - Signature Consultants (Boston, MA)
- Job Summary:Dexian is seeking a CMC PM for an opportunity with a client located in Boston, MA.Responsibilities: Creating and executing long- and short-term plans ... setting targets for milestones and adhering to deadlines while facilitating all project management schedule activitiesDelegating tasks on the project … more
- Sunrise Systems Inc (Seattle, WA)
- …50% + Onsite Top Skills: 5+ years' experience in bio tech/life sciences project management ; cell Therapy experience preferred. Bachelor's degree in STEM/Life ... Sciences-related discipline. Project management qualification preferred Proficiency with related...analytical method development & transfer. Job Description The Technical Project Manager ( PM ) will be a key… more
- Aequor (Thousand Oaks, CA)
- …authoring, reviewing and defending critical product impacting non-conformances? Experience in Project Management in support of product development? Knowledge of ... small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management … more
- 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
- Genmab (Princeton, NJ)
- …for overall budget and project plan deliverables, working closely with Project Management Team members to ensure alignment on budget, resource, and ... timelines. Partner with Project Management team member(s) to ensure execution against strategy, track progress, and communicate effectively within the team and… more
- Genmab (Remote, OR)
- …statistics, programming, trial management , data management , regulatory, nonclinical, CMC , and project management . The successful candidate will have ... Medical Writing. This is and individual contributor/technical position, not people- management position. As Associate Director, Medical Writing, you will serve… 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)
- …+ 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
