- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,... Network Leader , Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities...oversight to the CAPA program for the CAR-T manufacturing site .Oversee metrics, trending, and reporting of relevant quality… more
- Repligen (Clifton Park, NY)
- …for harmonization for matrixed roles. Lead all operations at the site , including Planning, Procurement, Manufacturing, Distribution, Engineering, Quality and ... OverviewThe Operations Leader role for Repligen is a senior position...candidate will play a key role in delivering the site expansion programs, implementing quality management systems… more
- Merck & Co. (Durham, NC)
- …vaccine manufacturing facility in Durham, North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, ... Job DescriptionOur Company is a trusted global leader in human and veterinary medicine, dedicated to...our customers, animals, society, and our planet.We have a site leadership role in our EHS organization available which… more
- Merck & Co. (Rahway, NJ)
- …enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development and commercialization of ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance ... an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, 12… more
- Merck & Co. (Durham, NC)
- …needs to identify solutions.Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve ... work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work...capable of managing change in the pursuit of continuous improvement. Lead projects for a facility or the site… more
- Merck & Co. (Durham, NC)
- …for calibration technicians.Works as a liaison between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve ... change in the pursuit of continuous improvement.Support projects with the potential to lead projects for the site .Able to train individuals in the execution… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Specifications, and Qualification Protocols) with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS ... be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the… more
- Merck & Co. (Durham, NC)
- …to align to SAP and business processes related to any new project implementations. Site supply chain lead and coordinator for the successful implementation of ... the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines,...operations, both on the main campus as well as off- site (3rd party) storage facilities.- The successful candidate will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Millsboro, DE)
- …an interdependent global manufacturing network that's committed to delivering a high quality , reliable supply to customers and patients on time, every time.Our ... processing (water in oil emulsions, aseptic filling, lyophilization, etc.), the Millsboro site supplies and supports products for a wide range of species including… more
- Merck & Co. (Rahway, NJ)
- …action (CAPA).- Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & ... Operations Engineering group (Pharm Ops Engineering). The role is on- site and reports to the Sterile Pharm Ops Engineering... and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations… more
- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.The incumbent will be responsible… more
- Merck & Co. (Rahway, NJ)
- …within a regulated supply environment.Responsibilities include but are not limited to: Lead and oversee analytical investigations with a strong focus on quality ... materialsEnsure a compliant, robust, and responsive supply chainIntroduce and lead strategic initiatives related to technical advancement, compliance, and business… more
- Merck & Co. (Rahway, NJ)
- Job Description Responsibilities :This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early ... the development of programming standards to enable efficient and high- quality production of programming deliverablesProvide technical consultation and analytical… more
- Merck & Co. (Rahway, NJ)
- …focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... site -specific projects, facilitate technology transfer, and drive product robustness...launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and… more
- Merck & Co. (Durham, NC)
- … Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing ... Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability… more
- Lundbeck (Indianapolis, IN)
- …South Bend and Toledo, OH SUMMARY: Are you a results-driven biopharmaceutical sales leader looking to be part of an organization that values being curious, adaptable ... for promotedproducts within our psychiatry portfolio . Set and lead the development of area strategic direction and tactical...redirecting efforts as needed to deliver high productivity and quality of work from self and others. Assures adherence… more
