- Merck & Co. (Rahway, NJ)
- …Lead establishment of test methodologies, including method development and validation , internally or externally, per design verification strategy. Lead ... Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our… 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 ... Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and… more
- AUROBINDO (Durham, NC)
- …Prescriptions Dispensed. (We are#27 in 2010)Job OverviewCapable of performing technical review of laboratory experimentation against test methods, internal standard ... operating procedures, and cGMPs. Previous GMP laboratory experience and technical reviewer experience are required. Review experience within an electronic laboratory… more
- BioAgilytix (Durham, NC)
- …life-changing, life-saving therapeutics to the patients who need them.The Cybersecurity Lead will be responsible for building and leading BioAgilytix's global ... security posture across a multi-site, regulated CRO environment. The Cybersecurity Lead will unify existing policies into a streamlined, risk-based framework, ensure… more
- Merck & Co. (Rahway, NJ)
- …Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline ... post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various… more
- Merck & Co. (Rahway, NJ)
- …to shape the technical capabilities and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical ... the analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead , mentor, and develop a team of technical staff,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform ... Packaging and Assembly Technical Leadership will be responsible and accountable for ...team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Technical Trainer as part of the Technical Operations team based in Raritan,… more
- Eisai, Inc (Exton, PA)
- …Provide technical expertise and direction to the development and validation of phase-appropriate analytical methods to support current and future programs. ... and stability testing activities; direct product characterization and assay validation . The individual may be required to perform hands-on...will be expected to be a resource for resolving technical issues at CMOs and CROs. The individual will… more
- Merck & Co. (Durham, NC)
- …diverse areas including Operations, Automation, Global Engineering, Safety, Process Development, Technical Services, and Validation .We are seeking a Maintenance ... Manager in Durham, North Carolina to lead a team of high performing Maintenance Technicians. The...performing Maintenance Technicians. The Manager will provide direction and technical guidance to maintenance technicians for a capital project… more
- Merck & Co. (Rahway, NJ)
- …regulations). Actively seek out, anticipate, and solve significant scientific and technical challenges. Lead complex investigations into technical challenges ... resolve issues effectively.- Additionally, coach and mentor others to grow their technical rigor to lead and/or contribute to investigations and… more
- Merck & Co. (Durham, NC)
- …for providing technical support to Durham current and pipeline vaccine manufacturing- Lead technical and business system process improvement projects- Lead ... Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation . Position Description:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … validation activities for cell therapy platforms.Work cross-functionally across Technical Operations and interface with external vendors to drive the design ... Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Compliance Auditor… more
- Formation Bio (New York, NY)
- …patients faster and more efficiently.About the PositionFormation Bio is seeking a hands-on technical leader to shape the future of our Data Curation team. This role ... biomedical and healthcare data into high-quality, stakeholder-ready assets. You'll lead efforts to transform structured, semi-structured, and unstructured data into… more
- Insmed Incorporated (San Diego, CA)
- …Regulatory Affairs, and external partners.What You'll Do: EDC System Design & Development: Lead the setup, development, and validation of EDC systems, including ... we're in. Are you?About the Role:The Associate Director, EDC Programming will lead and oversee EDC programming, and database build for in-house clinical trials.… more
- Insmed Incorporated (NJ)
- …activities to ensure phase-appropriate compliance.Actively represent QA in technical development activities, including process development, method validation ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from… more
- Genmab (NJ)
- …as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until proof of concept, and/or as trial responsible ... statistician.ResponsibilitiesCompound/Indication LevelAct as lead and main point of contact related to Statistics for designated compound/indicationFollow scientific… more
- Aequor (Davie, FL)
- …Summary: We are seeking a dynamic and technically skilled Automation Engineer to lead and support cross-functional initiatives across IT, OT, and controls systems in ... Use Copilot and Power Fx to simplify app creation and automate repetitive tasks. Validation & Compliance o Ensure systems meet GxP, FDA, and ISO standards through… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES end users to define change ... with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. This individual will… more
- Merck & Co. (Rahway, NJ)
- …experimental design and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The ... Associate Director will lead a team of technical experts responsible providing Logistics and Distribution Technology Center of Excellence support to the… more
