- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... the QA Investigation Supervisor within the Raritan Investigation Excellence Team . The QA Investigations Lead is responsible for providing quality oversight… more
- Merck & Co. (Rahway, NJ)
- …lead and support facility operations, process development activities, compliance investigations /change management, authoring of GMP documentation, and lead ... project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant...work cooperatively with other members of the SSO leadership team and SSO partners to drive overall success of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and GMP compliance. ... to drive operational excellence in a highly regulated environment.Key Responsibilities Lead manufacturing and cross functional investigations from end to… 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 experts ... the analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead , mentor, and develop a team of technical staff,… more
- Insmed Incorporated (NJ)
- …providing expert input on GMP requirements and ensuring alignment with global Quality strategy. Lead and develop a team of 2-8 Quality professionals supporting ... 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
- Merck & Co. (Rahway, NJ)
- …testing of small molecule, biologic, and vaccines finished drug products.Troubleshoot and lead any investigations associated with GMP testing through active ... and a resounding passion for improving human health. As part of our global team , you will have the opportunity to collaborate with talented and dedicated colleagues… more
- Eisai, Inc (Exton, PA)
- …The person will author protocols; reports; author and revise SOPs and lead investigations into assay failures, OOS/OOT events; direct the implementation ... The person will author protocols; reports; author and revise SOPs and lead investigations into assay failures, OOS/OOT events; direct the implementation… more
- Aequor (Thousand Oaks, CA)
- …the PQ organization as a subject matter expert of quality system records. In this team -based role you will directly add to the success of the Product Quality team ... International Quality and Process development on projects, issue resolution and investigations . The QA Specialist will be encouraged to use technical abilities… 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 experts ... the analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead , mentor, and develop a team of technical staff,… more
- Eisai, Inc (Nutley, NJ)
- …Operations will be a key member of Eisai's US Ethics & Compliance team , responsible for implementing the execution and evolution of Eisai's Compliance Monitoring ... days on site in Nutley, NJ (Tuesday Wednesday and Thursday). Key Responsibilities Lead the development and execution of the annual Ethics & Compliance monitoring… more
- Merck & Co. (Rahway, NJ)
- …testing of small molecule, biologic, and vaccines finished drug products.Troubleshoot and lead any investigations associated with GMP testing through active ... and a resounding passion for improving human health. As part of our global team , you will have the opportunity to collaborate with talented and dedicated colleagues… more
- Merck & Co. (Rahway, NJ)
- …- Be a Catalyst for Innovation! If you're passionate about biologics and ready to lead a high-impact team , apply now and be part of a transformative journey ... Job Description Join Our Team as a Biologics Cell Culture Leader! The...technology transfer to internal and external manufacturing sites, manufacturing investigations , process validation, second generation process development and authoring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Continuous Improvement: Lead effective communication efforts within the Medical Affairs team , ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, ... of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and act… more
- Vaco by Highspring (Charlotte, NC)
- …areas across multiple territories/worksites.Be a key member of the HR leadership team , providing both strategic and tactical support for a region covering 700-800 ... inquiries, including onboarding, benefits, FMLA, I-9s, employee relations, and investigations .Ensure HR compliance with both legal requirements and company policies… more
- Insmed Incorporated (NJ)
- …focus on inhalation-specific testing (eg, APSD, MMAD, delivered dose, particle size distribution). Lead and approve deviation investigations , OOS, and OOT results ... oversight for laboratory operations, including routine testing, data review, investigations , and documentation. The individual will work collaboratively with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Merck & Co. (Rahway, NJ)
- …design and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team .The Associate Director will ... based on the analysis of inputs, outcomes, risks, and company-wide prioritization.Essential Responsibilities: Lead , mentor, and develop a team of technical staff,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Buyer/ Planner Specialist as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis individual will work within Technical ... supplier documentation and statements.Monitor product life cycles and alert appropriate team members to any actionable inventory requirements and disruption to… more
- Repligen (Clifton Park, NY)
- …and create drawings and make recommendations for continuous improvement.ResponsibilitiesManage and lead maintenance team during routine PMs, projects, new roll ... basic/routine equipment maintenance and optimization while following all safety measures. Lead projects, schedule repairs and maintenance to adhere to manufacturing… 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 experts ... the analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead , mentor, and develop a team of technical staff,… more
