- Merck & Co. (Rahway, NJ)
- …operations, process development activities, support compliance investigations/change management, author GMP documentation and manage/ lead engineers in any of ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility is appropriately purchased, qualified, deployed and maintained following necessary GMP requirements. Technical lead for equipment optimizations as well ... manufacturing as well as facility expansions and improvements.Key Responsibilities Lead implementation of system/equipment changes from identification through implementation/release,… more
- BioAgilytix (Durham, NC)
- …therapeutics to the patients who need them.Essential ResponsibilitiesServe as lead scientist on assay development, validation, and sample analysis project ... Follow GMP guidelines for validation of assays and sample analysisIndependently...to experimental planning and design Preferred experience working in GMP environments and demonstrated knowledge of GMP … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaborate with cross-functional teams, and ensure seamless technology transfers to GMP manufacturing groups.Key Responsibilities Lead the development of ... As a senior member of the team, you will lead the design, execution, and interpretation of complex process...and present data in a clear and concise mannerEnsure GMP compliance in laboratory notebooks, protocols, and reportsCollaborate with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities for supporting the document ... facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements ... and investigational purposes, drug substances, intermediates and service providers provide GMP compliant activities ensuring the stable and quality supply as per… more
- Merck & Co. (Rahway, NJ)
- …New Jersey provides a launch pad for the formulation development and early phase GMP clinical supply capability of Oral and Specialty products.- The Lead of ... They will be responsible for operating and maintaining a compliant, GMP -licensed manufacturing facility with the capability to rapidly manufacture supplies for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy 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, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to… more
- Insmed Incorporated (San Diego, CA)
- …CMC teams you will be the bridge between the laboratory and GMP manufacturing.ResponsibilitiesWorks with management to plan and execute the MSAT department strategy ... activities, coordination of process start-up activities including Engineering Runs, GMP /clinical, PPQ and routine commercial runs, and resulting risk mitigation… more
- Lundbeck (Bothell, WA)
- …Expert (SME) in the transfer of analytical methods from Lundbeck to GMP contract labs/contract manufacturing organizations (CMOs) Collaborate with QC to ensure ... successful method validation at contract labs/CMOs; support investigations and lead troubleshooting efforts as required Collaborate with Lundbeck research to… more
- Merck & Co. (Rahway, NJ)
- …The Specialist - Manufacturing Automation position will report to the Director, Engineering, Automation Lead position and will be a member of the EF Team at the ... Manufacturing Division, Animal Health and GWES. The system is GMP and monitors areas and equipment that are both...calibrated and qualified as required.- Also, this role will lead any future changes to the system such as… more
- Merck & Co. (Durham, NC)
- …the area succession plan FINANCIAL MANAGEMENT Assists Engineering & Maintenance Lead with managing the Engineering & Maintenance cost center, including capital ... shutdown execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdownsCoordinates with Durham Site… more
- Merck & Co. (Rahway, NJ)
- …formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include the-development of ... of Position:The Director reports to the Executive Director of SMAR&D and will lead a team in Rahway (~10-15 scientists) who work closely within multidisciplinary… more
- Merck & Co. (Rahway, NJ)
- …representative for, and providing quality oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus on ... partner with internal development teams on objectives utilizing external contractors including GMP qualification as well as the support of small and large molecule… more
- Merck & Co. (Durham, NC)
- …the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.The ideal candidate for this role will be an ... State and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment, and safety,… more
- Aequor (Bothell, WA)
- …A minimum of 5 years of relevant Quality experience in a GMP /FDA regulated environment. Understanding of Quality Risk Management principles and application within ... this role supports the use of various risk management tools to lead complex cross-functional issue resolution by employing a methodical approach to root… more
- Aequor (Vacaville, CA)
- …Direct Materials Requirements Planner is responsible for planning and buying of GMP direct materials for Vacaville manufacturing. This person has planning buying ... maintain relationships with relevant internal and external stakeholders and participate/ lead discussions, problem solving efforts and process improvements to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy products for clinical trials and commercial operations in a controlled GMP environment. This position is primarily a M-F schedule, with potential nights ... or weekends temporary coverage.Key Responsibilities This individual will lead and supervise onboarded CAR-T new hires through their initial training process up to… more
- Merck & Co. (Millsboro, DE)
- …leadership of the Animal Services Department.Essential Duties / ResponsibilitiesAssociate Director: Lead and develop a team of animal care and testing ... Senior Leadership Team for the Millsboro, DE biologics manufacturing site. Lead numerous projects including process improvement and safety initiatives.Coordinate /… more
- Merck & Co. (Millsboro, DE)
- …at the Millsboro, Delaware site reports to the Site Quality Head and will lead the activities of the Quality Assurance team, as well as influence and execute ... knowledge of regulatory requirements in accordance with both USDA and GMP regulations for veterinary biologicals.Experienced in leading domestic and international… more
