- HEPCO, Inc. (Belleville, NJ)
- …Analyze data and synthesize insightful recommendations for management. Lead , facilitate, and communicate across stakeholder functions, business lines, ... and suppliers while ensuring system controls comply with policies and procedures. Work with software/service providers and internal stakeholders to identify, track, and resolve system and data issues or enhancements. Translate business problems into technology… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our tech strategy through 0-to-1 ... product conceptualization, rigorous research and experimentation, and iterative development of new products. You will interview, shadow, and collaborate with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management,… more
- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …(SMAR&D) group has an exciting opportunity for a director role as Strategic Operations Lead based in Rahway, NJ. As the Strategic Operations Lead within the ... SMAR&D GxP Operations group, you will drive the strategy and logistics for the team responsible for analytical release of raw materials, package components, medical device components, clinical drug substance, and clinical drug product for our small molecule… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... Trial Master Files (TMF) with CSO-related documents.Supports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of ... services are developed, implemented, tested, and integrated efficiently and effectively. The Lead will define and drive the methodology, approach, and best practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing ... or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global product team meetings to provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Technical Lead will ... continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the...Management and Integration Lead and Process Validation lead on the establishment and management of a process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Cleaning Validation Lead as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Cleaning Validation Lead ... following necessary FDA / Annex 1 requirements. This person will be the lead for cleaning validation program, working cross functionally with various departments to… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting ... documents outside of QA. Assure the execution of QA Audit Plans, Lead internal and external audits to assess compliance with regulatory requirements, track… more
- Formation Bio (New York, NY)
- …Given our hub-and-spoke model, this role offers a unique opportunity to lead a diverse range of transactions, from acquiring assets to structuring partnerships ... transactions are strategically aligned, financially sound, and efficiently executed.Responsibilities Lead Deal Structuring & Negotiation: Drive negotiations for asset… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionWe are seeking a seasoned Staff Engineer to lead our AI Foundations Team-a new initiative dedicated to establishing the core ... ecosystem, we'd love to hear from you. ResponsibilitiesArchitectural Leadership: Define and lead the end-to-end design of our AI Platform, ensuring robust, scalable,… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.Responsibilities Lead the design, development, and deployment of software solutions that leverage ... is a plus, but not required. What You'll Do Engineer the Future: Lead the design, development, and deployment of cutting-edge software solutions using AI/LLM… more
- Formation Bio (New York, NY)
- …the consistent production of safe, effective, and high-quality pharmaceutical products. Lead internal and external audits to assess compliance with regulatory ... improve quality performance. Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive… more
- Formation Bio (New York, NY)
- …development decisionmaking and workflows, tech/AI opportunities, and industry dynamics Process Lead Product team in effective discovery and research to understand ... practices for Design productivity, quality, and cross-functional collaboration People Lead the Product Design team in delivering high-impact, high-quality products… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility for the ... group and in the field of Thoracic Oncology .The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy,… more
- Lundbeck (New York, NY)
- …ability to instill trust and drive results through others. Demonstrated ability to lead a region and leadership team in creating and executing strategic plans. ... Ability to develop talent through the identification of development strategies and resources, with an emphasis on feedback and coaching. Robust financial acumen. Exceptional communication skills. Strong analytical capability. Meeting and complying with… more
- Merck & Co. (Rahway, NJ)
- …customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...clinical bulk activities in addition to serving in a lead role for clinical supply issue escalation within their… more
