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The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process, equipment, and associated deviations and investigations within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.
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Minimum 5 years of Process Automation engineering (Levels 0-2); OSI-PI, Equipment PLC, SCADA, DeltaV DCS, Middleware, and integrations with MES (Level 3). Lead and improve the capabilities of CAR-T Process Level Automation systems (OSI-PI, Equipment PLC/SCADA, BMS, EMS, IDP (Instrument Data Platform) in compliance with site local and global procedures.
$76,000 - $121,900 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Daily use of MS Teams/ Smartsheet to organize upcoming deliverables, process flow, due dates and budget to enable team to function at higher level and meet commitments. Leading Pharmaceutical Company located in NJ is hiring a Manager, Global Medical Affairs Strategy and Execution w/ 5+ years industry experience.
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2+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is preferred. Knowledge of pharmaceutical cGMP (US and EU) is preferred.
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Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. A higher-level resource who is qualified and experienced in enterprise risk tolerance, Commercial business acumen, relationship-building and negotiating prowess, while being a seasoned Quality-minded professional.
$52 - $67 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.
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A minimum of 5 years of combined relevant experience in a medical/clinical environment, scientific function in the pharmaceutical industry is preferred. Partner with Scientific Communications agency and publication vendors /GMAPP team to manage the details and process for preparation of landing pages for Congress materials.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Responsible for maintaining compliance with FDA, AATB, international and state regulations during the second level quality review of all tissue donor files for tissue submitted to Allergan to ensure the safety of donated human tissue.
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Experience leading a study (observational, non-interventional) to support market access needs is desirable. Oversight of process and deliverables (One-pagers; Pub Plan; Bibliography, Metrics; abstracts eligible for encore.
ExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Mathematical proficiency; Dexterity; Successful completion of written and hands on competencies; Technical expertise (site level) for Automated Dispensing Cabinets (ADC) (e.g. PYXIS® or Omnicell®); Competence in required computer programs (clinical system, ADC, packaging, parenteral documentation.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 year of experience as a Clinical Data Manager II, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Senior Level individuals, Technology Quality GxP experienced, Experienced on Acquisition and Divestiture with previous engagement on Clients projects. Candidate must have worked with Pharmaceutical in the past.
ExpandApply NowActive JobUpdated 7 days ago
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