- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production...the planning and execution of internal audits for all quality system areas for the manufacturing site ;… more
- Merck & Co. (Durham, NC)
- …product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will ... CLUE and SAP).Support and maintain a "Safety First", " Quality Always" environment with participation in Site ...metrics.- Consults on an as-needed basis with next level manager on more complex decisions.Actively sponsor and develop a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the compliance program for the site Quality Control laboratories in support of both clinical and commercial ... myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team...manufacturing. This role will be responsible for managing Laboratory Quality Investigation Leaders, approving critical site Laboratory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Trial Manager Experience with global clinical trial operations, in multiple phases of research Strong knowledge of ICH guidelines, GCP and FDA ... R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma.Legend Biotech is seeking a QA Batch Warehouse Associate Manager as part of the Quality team based in Raritan, NJ. Role ... readiness of records for regulatory inspections and internal audits.Ability to utilize multiple electronic quality systems and SAP.Knowledge of cGMP regulations… more
- Merck & Co. (Durham, NC)
- …to meet performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review and review ... Job DescriptionPosition Description: Specialist, Quality Assurance 1st Shift - Our Company constructed...aseptic observations, cleaning techniques, and gowning observations. Partner with site functions to solve problems and achieve goals. Makes… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist, Quality Systems and ComplianceOur company is expanding its global recombinant vaccine production network by investing and adding a ... the vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.The Quality Senior Specialist provides expertise in the coordination of… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct a new manufacturing facility to significantly expand its ... including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Senior Quality Assurance Specialist will… more
- Insmed Incorporated (Phoenix, AZ)
- …for data entry, triaging documentation, and supporting the Patient Services Case Manager team throughout the patient treatment journey. The role requires dedication ... pharmacy on patient status of pending patient casesSupport Patient Services Case Manager team with daily tasks and assigned patients, starting with welcome,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the ... quality and process validation requirements for existing products. Participate...experts to prepare for FDA and other agency auditsEnsure site /system validation program meets FDA, ISO and EU requirementsCollaborate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and actions site query responses. Performs medical coding line listing quality reviews for accuracy and consistency within and across programs on an ongoing ... around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical...safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug… more
- Lundbeck (Minneapolis, MN)
- …and transform lives. Join us on our journey of growth! As an Area Sales Manager (ASM) you will be responsible for leading, developing, and managing a diverse, high ... People Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of ... individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe… more
- Merck & Co. (Durham, NC)
- Job DescriptionM 1 Operations Manager - - Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a ... "Safety First, Quality Always" mindset striving for continuous improvement. We work...Durham employs 1,000+ people. - This role as a Manager , Operations will be an energetic, leader with strong… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …trial site staff, clinical research vendors). Manages relationships with multiple internal stakeholders relevant to the planning and implementation of clinical ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Merck & Co. (Durham, NC)
- …The Sr. Maintenance Scheduler is a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy ... Vaccines Manufacturing and Bulk Facilities (B101, B102, B130, B150 and B160), Quality Labs, Maintenance and Material Storage Facility (MMSF) and Teknika Facilities .… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Oversight Specialist role is an exempt level position with responsibilities for providing quality oversight over the site Quality Control laboratories ... the quality control laboratories.Key Responsibilities Be responsible for providing quality oversight for site Quality Control laboratories responsible… more
- Merck & Co. (Durham, NC)
- …3-weeks rotation which includes a weekend every three weeks.The role of Operations Manager at our company is a manufacturing leadership role. The individual in this ... become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to resolve process/equipment issues, minimize downtime, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Trial Manager Experience with global clinical trial operations, in multiple phases of research Strong knowledge of ICH guidelines, GCP and FDA ... R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global… more
- Merck & Co. (Durham, NC)
- …guided by policies, procedures and business plan; receives guidance from manager .Contributes to the performance and results of the department.Identifies and resolves ... implementation of new systems which enhances the operation and/or engineering processes. Quality & Safety Compliance:The successful candidate should be able to… more
