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Overview Medical Device – Wound Care Sales – Biologics: My medical device client is an innovative company that develops and manufactures regenerative therapies for wound and tissue repair. Profile: Medical Device Sales selling Biologics, Regenerative Medicine or Wound CareMust have experience/ relationships within hospitals within territory.
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Or more years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies. or more years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies.
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Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
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Job DescriptionThe Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.
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Responsibilities:Independently manage development projects of any type, including those that require experience with drug/vaccine/biologics development, the PMO processes and procedures related to development teams due to their significant importance to the company or complexity.
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Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. The latter two together form our Biologics' Process Development (BPD) group.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
$84 - $87 an hourExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents.
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Keywords: clinical supplies, biologics, vaccines, electronic batch record review, batch record, cGMP, SOPs, specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA, Quality Assurance.
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5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
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Our Pharmaceuatical client is seeking a SDLC and GMP Documentation Specialist to join their team in West Point, PA. This individual will primarily support the BCMT Automation team supporting the GMP Biologics Pilot Plant.
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Position SummaryThe Executive Director, Analytical Strategy and Operations (ASO) reports to the Vice President and is a key analytical strategic leader for Product Development and ASO. This leader is responsible for the integration and alignment of analytical strategies to ensure product quality and safety of small molecule and biologics drug substance and drug products and is responsible for managing extensive internal and external analytical network.
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Experience in developing CMC regulatory strategy. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.
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3+ years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies. 3+ years industry experience in Laboratory Operations or related function in clinical / commercial biologics, cellular therapy, or gene therapy biotech companies.
ExpandApply NowActive JobUpdated 4 days ago
biologics job in Rahway, NJ
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