- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.Perform analysis on quality indicating data and… more
- Merck & Co. (Durham, NC)
- …to strategic workstreams, knowledge sharing, and process improvement projects. Lead projects through all phases including project planning, project management ... forums and maintenance of product historical knowledge and best practices. Lead complex process investigations, including multi-site coordination and technical… more
- Merck & Co. (Durham, NC)
- …of plans and resolution of issues.Collaborate with commercialization and internal /external manufacturing sites to enable on-time, right-first-time vaccine technology ... industry technical business processes such as:- technical documentntation, change control , portfolio management, risk mitigation, deviation management, technical protocols/reports,… more
- Eisai, Inc (Exton, PA)
- …want to hear from you. Primary responsibility will be to maintain the various control systems throughout the pilot plant facility as well as the laboratory building. ... The control systems include process skids, clean utilities, dirty utilities,...reviewing and overseeing PM's.This position will also work with internal and external personnel to develop validation documentation and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessment, and continuous improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations ... Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy manufacturing processes.… more
- Merck & Co. (Rahway, NJ)
- …regulatory compliance.-Essential Duties and Responsibilities:Utilize extensive experience in design controls , device transfer, control strategies, device risk ... 4 years in managing external partners and suppliers.Proven expertise in design controls , risk analysis, control strategies, design verification testing, and… more
- Merck & Co. (Rahway, NJ)
- …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 ... the robustness and compliance of our company's product portfolio across the internal and external networksThe candidate is expected to build inclusive, collaborative… more
- Merck & Co. (Rahway, NJ)
- …cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams.- The leader will be responsible for executing ... the robustness and compliance of our company's product portfolio across the internal and external networksThe candidate is expected to build inclusive, collaborative… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and participate in the creation, revision and review of change controls , SOPs, and other documentation.RequirementsBachelor's degree in Engineering, related field, ... pharmaceutical environment with adherence to strict regulatory guidelines and internal compliance policies.In depth understanding of cleanroom manufacturing, aseptic… more
- Merck & Co. (North Wales, PA)
- …Equipment team, in providing technical leadership and support to our company's internal & external packaging network, focusing on developing and executing packaging ... processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... on tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Repligen (Clifton Park, NY)
- …support, while serving as a technical subject matter expert (SME) and team lead . The position also plays a key role in supporting change management, continuous ... issues.Develop and implement PM schedules, calibration plans, and equipment operation SOPs. Lead or support facility and equipment projects from planning through… more
- Aequor (Vacaville, CA)
- …OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational ... Perform equipment qualification / maintenance Prepare and maintain standards, controls , stocks, cultures, etc. per established procedures Support the maintenance… more
- Merck & Co. (Rahway, NJ)
- …scope, and regulatory compliance as well as act as a liaison with internal department stakeholders and external consultants to gather input and facilitate planning ... ensuring alignment with Our Company's strategic goals.Develop liaisons with internal departments and community organizations to gather input and facilitate… more
- Merck & Co. (Rahway, NJ)
- …as part of a matrix team including product development teams and internal partner groups (quality, analytical,- procurement, and global clinical supply). Projects ... to day-to-day coachingDevelop broad strategies to improve current practices with internal and external stakeholdersMaintain a strong knowledge of the external vendor… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... the successful completion of projects. This includes technical support to the internal and external manufacturing sites as well as Third Party Logistics providers… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... (CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts… more
- Merck & Co. (Rahway, NJ)
- …principal scientist advocates technical growth opportunities through collaboration with internal resources and academic or industrial partners.- In partnership with ... and/or the Head of the Crystallization Lab, the principal scientist may lead strategic technical initiatives and support talent development of junior engineers.A… 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)
- …analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills. ... the group Director to define group strategy and to lead a team of scientists in solving complex analytical...and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related… more
