- Novo Nordisk Inc. (Boulder, CO)
- …RNAi therapeutics, continuing its legacy as the hub for all manufacturing -related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from ... and is one of the world's leading centers for oligonucleotide innovation and manufacturing . Together, we are driving change. Are you ready to make a difference?… more
- Merck & Co. (North Wales, PA)
- … to our partnership in support of the V940 Individualized Neoantigen Therapy (INT) program .Provide Quality leadership as part of the new Quality Platform to ... Job Description Description: Reporting to the AVP of New Modalities our Manufacturing Division Quality, this leader is responsible for supporting the implementation… more
- Merck & Co. (Rahway, NJ)
- … considerations and scale-up/tech transfer activitiesDemonstrated experience solving program challenges by leveraging a breadth of experiences, including ... to medicines, working from the discovery interface through registration stability manufacturing by designing, developing, and scaling up the formulation, device, and… more
- Novo Nordisk Inc. (Boulder, CO)
- …RNAi therapeutics, continuing its legacy as the hub for all manufacturing -related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from ... and is one of the world's leading centers for oligonucleotide innovation and manufacturing . Together, we are driving change. Are you ready to make a difference?… more
- Insmed Incorporated (Bridgewater, NJ)
- …years of Project/ Program Management experience with proven management and/or leadership experience in an R&D, manufacturing /operations or commercial context ... Director of Program Management will provide cross-functional operational and program management leadership , strategic thinking, and business acumen for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various ... support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be… more
- Merck & Co. (Rahway, NJ)
- …is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to support ... growing pipeline of oral and injectable therapeutics and vaccine drug products. Operational leadership of the FLEx complex is shared across two co-leader roles, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally ... resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for… more
- Merck & Co. (Rahway, NJ)
- …in some 150 markets.Accountable for all Environmental, Health, and Safety (EHS) program execution and compliance at our Manufacturing Division's Animal Health ... issues with tact and diplomacy in a timely fashion.Proven experience leading a site program such as Manufacturing , Research, Tech Ops function, Quality or EHS… more
- Catalent (San Diego, CA)
- …Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site Leadership Team, you will partner with the General Manager to create and sustain a ... of the Senior QA Manager include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of… more
- Catalent (St. Petersburg, FL)
- I. Department Overview: The Quality Assurance Department is responsible for providing leadership and support to the Catalent St. Petersburg site. The Department has ... trending and follow-up of the CAPA programs. Interacts directly with the manufacturing personnel and is responsible for maintaining a high-quality environment within… more
- Catalent (Harman, WV)
- …engagement and motivation. Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily ... action items for completionSupport client projects and provide quality oversight of manufacturing operations and the release of drug substance and/or final drug… more
- Merck & Co. (Durham, NC)
- …providing equipment troubleshooting and maintenance support for ongoing facility facility/ manufacturing operation and support growth initiatives at the site. Assists ... to correct Plant Engineering maintenance problems. Responsible for supporting our Manufacturing Division,- Divisional site mission by assuring quality of products… more
- Catalent (Harman, WV)
- …for ensuring the environmental monitoring and control of the manufacturing environment and plant hygiene.Require approval and monitoring of suppliers ... orderly manner to allow rapid retrieval when required.Being part of the Site Leadership Team representing the QRA function for the site and supporting site… more
- Insmed Incorporated (Bridgewater, NJ)
- …which include oversight of raw material qualification, lab investigations, stability program , etcProvide oversight of QC equipment program , which includes ... active participation on Joint Steering Committees, frequent communication with QA Leadership , and direct support of Insmed Person In Plant (PIP).Responsible for… more
- Novo Nordisk Inc. (Boulder, CO)
- …RNAi therapeutics, continuing its legacy as the hub for all manufacturing -related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from ... and is one of the world's leading centers for oligonucleotide innovation and manufacturing . Together, we are driving change. Are you ready to make a difference?… more
- Catalent (Manassas, VA)
- …consultant and the auditor. The position will develop, monitor, and validate the Sanitation Program to ensure that the manufacturing areas and the general office ... safety/quality related training event Prior experience in food processing, within a manufacturing environment under HACCP, and SQF Demonstrated leadership in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for batch record review activities for the site. Oversees quality shop floor program to ensure compliance of the manufacturing operations. Responsible for ... CAR-T is responsible for Quality oversight and support of c ell therapy manufacturing operations , in full complianc e with established cGMP requirements. Functions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA program for the CAR-T manufacturing site. Oversee metrics, trending, and ... responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a… more
- Merck & Co. (Millsboro, DE)
- …of animal care and testing specialists.Serve as a member of the Senior Leadership Team for the Millsboro, DE biologics manufacturing site.Lead numerous projects ... animal facilities as well as for the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This role is highly… more
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