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Reporting directly to the Senior Manager of Quality, this position collaborates closely with External Manufacturing Organizations (EMO), spanning pharmaceuticals, medical devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements.
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GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers.
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Contributes US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications. As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics.
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Design and manage several facilities and process related capital projects (HVAC and utilities projects; biologics cell culture and purification upgrades; cryogenic storage capacity projects; laboratory and building infrastructure renovations; etc.
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Knowledge of ADC or other biologics, or small molecules preferred. Collaborates across GMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations.
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Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
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Bachelors or Master’sdegree in Life Sciences, Engineering, or BiotechnologyBroad industrial experience in the pharmaceutical business (>10 years)Deep SME and Operational knowledge of all core Sanofi manufacturing process and technologies suchincluding but not limited to Biologics and Vaccines, Filland Finish, Chemistry(OSD/API), Packaging and Device.
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Minimum 3+ years of industrial biologics CMC development or manufacturing experience, Cell therapy manufacture experience is highly desirable. Manage the CMO tech transfer and clinical/commercial manufacture: trouble shooting problems, conducting investigations, track timeline and KPIs, overseeing capacity expansion, monitoring budget, driving cost reduction and quality improvement and serve as Person in Plant.
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B.S. or more advanced degree is required, in related technical disciplines: engineering, biological science, pharmaceutical science etc. Drives and steers continuous improvement at the CMO and ensure timely execution of capacity, Tech Transfer and improvement projects.
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Our deep expertise in disease pathways helps us take aim at smart targets, while our unique technologies empower them to develop drugs, biologics, and genomic medicines with the potential to transform the practice of medicine.
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1 or More Years of Experience of working with the global regulatory landscape for at least 2 of the following: •Oncology drugs •Biologics/ADCs •Medical devices •Companion diagnostics preferred. This role will engage with a range of internal and external stakeholders from across functions on key regulatory topics, particularly relating to biologics and Oncology, incl.
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This position requires technical expertise in upstream and downstream process of biologics (Cytokines, monoclonal antibodies manufacturing). Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will be executing routine documentation work which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPA etc.
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We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing service work orders.
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Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics, advanced therapies, or pharmaceuticals. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics, advanced therapies, or pharmaceuticals.
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Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development.
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biologics job in Bridgewater, NJ
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