- Merck & Co. (Durham, NC)
- …industry technical business processes including:- technical documentation, change control , portfolio management, risk mitigation, deviation management, ... Job DescriptionVaccines tech product leadership (V-TPL) within large molecule science...cross-site issues, identify trends and participate in proactively implementing risk mitigation actions.Collaborate with functional teams to contribute to… more
- Merck & Co. (Durham, NC)
- …industry technical business processes such as:- technical documentntation, change control , portfolio management, risk mitigation, deviation management, technical ... Job DescriptionVaccines tech product leadership (V-TPL) within large molecule science...help identify trends, and participate in the implementation of risk mitigation actions.Collaborate with functional teams to contribute to… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key… more
- Merck & Co. (Rahway, NJ)
- …equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/ validation.Demonstrated ... cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment ... are executed in an effective, efficient, and compliant manner.Participate in Risk Assessments, FMEAs, and system/data process mapping activities.Execute, own, assess… more
- Merck & Co. (Rahway, NJ)
- …leadership will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and ... and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Rahway, NJ)
- …finished goods.- Development activities include the design, characterization, qualification, and tech transfer of robust packaging systems to commercial sites, as ... inputs, outcomes, risks, and enterprise-wide prioritization. Primary Responsibilities include: Lead a sterile product group, accountable for people and operations,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Merck & Co. (Rahway, NJ)
- …of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and ... to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable of discerning...others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in… more
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