- Bayer (Myerstown, PA)
- …products, and provide scientific feasibility information for go/no-go decisions. The Manager also supports technology transfer activities within internal ... regulatory requirements and industry standards related to the assigned technology ;Good project management and prioritization skills;Detail-oriented with strong… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …MES Project Manager will be part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to maximize your potential with us? The Position The Contract Manager role will be responsible for end-to-end processing of all in-scope service contracts ... with third-party vendors, across low, medium, high business risk and complexity, from intake to execution, in collaboration with SME reviewers, contract owners,… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:We're looking for a Sr Manager , IT Clinical Systems Validation in the IT team to help us expand what's ... expertise to validate and maintain the validated state of our expanding technology landscape ensuring the highest standards of regulatory compliance and data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …The Manager will play a key role in vendor management , contract negotiation, and operational procurement excellence.Key Responsibilities Support and lead the ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell… more
- Twist BioScience (South San Francisco, CA)
- …structures that create long-term value by balancing commercial opportunities with risk and operational feasibility.Contract Management : Create and negotiate ... The Senior Strategic Partnership Manager (SPM) is a critical role responsible for...and potential partners, including those in diagnostics, biopharma, and technology .Alliance Management : Support, maintain, and grow existing… more
- Formation Bio (New York, NY)
- …for and participation in regulatory inspections and due diligence audits Apply risk management principles (eg, FMEA) to guide decision-making Champion a ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... provide overall leadership and strategic direction for the clinical project management functions in a technology -driven, AI-focused biotech environment. This… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires deep expertise in privacy law, strong communication and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …file is complete and accurate for assigned stud(ies).Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT),… more
