- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... maintain current knowledge of cGMP regulatory issues, Good Automated Manufacturing Practices (GAMP5) and Good Practices Guides, Risk-Based Approach/Computer Software… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Manufacturing team in support of ongoing technical transfer and manufacturing operations . Write and/or review manufacturing process transfer plans, ... team in support of ongoing technical transfer and manufacturing operations . Support facility fit assessments for...solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …certification is a plus, with proven leadership in pharmaceutical industry, manufacturing / operations , or commercial contexts requiredA minimum of at least ... RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead innovation, coordination, and strategic planning efforts and will be responsible to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift ... Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie component preparation manufacturing , MFG support operations ,… more
- Tris Pharma (Monmouth Junction, NJ)
- Sr Project Manager, Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, ... changes + comm w/ FDA. Provide tech spt to manufacturing + packaging ops or other depts by leading...update plan + prioritize activities for successful proj implementation. Lead cross-funct meetings to ensure funct deliverables understood +… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Work in a collaborative team setting with quality counterparts that include Manufacturing Operations , Operations Technical Support, Maintenance, Supply Chain ... in the treatment of multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift) as part of the Quality team based in Raritan,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working groups; OOS and TAT strategic working groups) Drives solutions to complex manufacturing operations issues at internal and external manufacturing ... and leading complex investigations. Experience in driving consistency across multiple manufacturing sites. Extensive knowledge in cell therapy operations ,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing . This individual will work within an Operations Unit and ... treatment of multiple myeloma. Legend Biotech is seeking an Operations Process Trainer (2nd shift) as part of the...minimal supervision Proactive and continuous improvement oriented Ability to lead with influence cGMP manufacturing Able to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment. The lead QC Microbiology Data ... Raritan manufacturing processes, either for clinical trials and commercial operations in a controlled cGMP cleanroom environment. Create, review and approve… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA and QC oversight ... in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency projects, and… more
- Insmed Incorporated (Bridgewater, NJ)
- …(Process Chemistry) will have responsibility for the management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, ... research and early CMC development.Responsible for the management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including oversight of tech… more
- Tris Pharma (Monmouth Junction, NJ)
- …Improvements (CPIs)Works directly and cross functionally throughout company (ie, QA Operations , Quality Control (QC), Manufacturing , Operations , Technical ... Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site ... supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues. Key Responsibilities Read, interpret and revise documents such… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, ... for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA program for the CAR-T manufacturing... Lead the CAPA program for the CAR-T manufacturing site. Oversee metrics, trending, and reporting of relevant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support the Quality Leaders in meetings with quality counterparts that include Manufacturing Operations , Operations Technical Support, Maintenance, Supply ... Leads. Provide guidance to the Quality Leaders about handling the various nonconformances. Lead the daily touch point meetings with the team and monitor workload. … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of manufacturing processes and quality risks, and experience in pharmaceutical GMP Manufacturing Operations is a plus. Proficiency in MS Office, MS Project ... seeking Risk Assessment Specialist as part of the Technical Operations team based in Raritan, New Jersey. Role Overview...Projects to the cGMP Clinical and Commercial Cell Therapy Manufacturing Plant. In addition, the candidate must have Quality… more
- Catalent (Philadelphia, PA)
- …and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion ... with the QADC team.Act as site subject matter expert for "Good Manufacturing Practices" and SOPs related to batch record documentation and release.Act as… more
- Catalent (Philadelphia, PA)
- … Operations department. Act as site subject matter expert for "Good Manufacturing Practices" and "Good Distribution Practices"Act as lead investigator for all ... and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion… more
- Insmed Incorporated (Bridgewater, NJ)
- …with proven management and/or leadership experience in an R&D, manufacturing / operations or commercial context in a biotech/bio-pharmaceutical environment ... facilitating issue resolution, problem-solving, risk management, contingency planning and decision-making. Lead and direct integrated teams to plan, execute, control,… more
- Staffing Now (Princeton, NJ)
- …County area seeking a Finance Manager based out of the transportation/ manufacturing industry. Our client is offering an extensive PTO structure, holiday/ vacation ... auditors - Ensure compliance with all financial regulations and industry standards - Lead and mentor a team of finance professionals to support the financial needs… more
