- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level...of a Bachelor's Degree in Science, Engineering or equivalent technical discipline or relevant experience is required.A minimum of… more
- Merck & Co. (Rahway, NJ)
- …broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well as members of internal ... and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Technical Trainer as part of the Technical Operations team based in ... commercial launch and sustained production. The role will require technical experience, effective communication, coordination and collaboration across relevant cross… more
- Merck & Co. (Rahway, NJ)
- …and IT functions, and develop strategic digital roadmaps, and lead delivery of capital project digital programs.Responsibilities include:Planning and allocating ... emphasize collaboration in a matrixed organization.- Effectively communicate to both technical and non- technical audiences.- Familiarity with IT architectural… more
- Twist BioScience (South San Francisco, CA)
- …product management, customer relationship management, or products, systems , or applications experience.Excellent communication, collaboration, and ... Sr Technical Product Manager (Hybrid in South San Francisco...at the intersection of product, engineering, and business. You'll lead all aspects of product development from ideation through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Aequor (Houston, TX)
- …the initiation, investigation and completion of Minor process deviations o Demonstrates technical writing for the educated but uninformed reader, translate simple to ... most likely cause of the deviation investigation o Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP documents (ie SOPs,… more
- BioAgilytix (Durham, NC)
- …can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting yourself while laying out the roadmap for a future team.Just as ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Merck & Co. (Rahway, NJ)
- …on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical staff to support global and ... Organization. This position is responsible for providing strategic leadership, technical expertise, and project management in the scale-up, development,… more
- Novo Nordisk Inc. (Durham, NC)
- …as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better practices, ... site data and digitalization efforts with respective complexity (according to the technical development pathway) and with little to no guidance from the manager.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …identify system and technology development needs and to define functional requirements. Provide technical guidance to the development. Lead and may approve UATs. ... of BDM departmental (internal and external) R related analysis and programming technical issues and difficulties. Lead the trainings and implementations of… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... variance from targets and implement action items to improve performance.Apply technical skills and ingenuity to correct equipment and system problems that… more
- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute… more
- Aequor (Devers, TX)
- …Months with High Possibilities of ExtensionDescriptionThe Cell Therapy SAP Sourcing Migration Lead is located in Devens, Massachusetts. This role will report to the ... Devens Associate Director, Cell Therapy Site Procurement Lead and will follow the Client Hybrid work schedule...vendor setup from one ERP System to another ERP Systems (ie, Oracle to SAP). Dual Sourcing Setup: When… more
- Twist BioScience (South San Francisco, CA)
- …GxP regulations, industry best practices, and technological advancements in biotechnology . Technical Team Management: Lead , mentor, and develop a high-performing ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Merck & Co. (Rahway, NJ)
- …the principles of project management and clinical customer relationship management. - Technical Proficiency: familiarity with supply chain systems and software ( ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with… more
- Aequor (Thousand Oaks, CA)
- …a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected ... of interactions and collaboration is required across these groups, and the NPI Lead needs to be able to understand their business and manufacturing processes with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Director of Operations ... is an exempt level position working within Technical Operations. This individual will be responsible for overseeing the production of a personalized cell therapy to… more
- Merck & Co. (Rahway, NJ)
- …Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and ... Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products… more
