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The Head of Biopharma Biostatistics serves as a leader within the global biostatistics department responsible for strategic and operational oversight of the biostatistics and statistical programming activities for Emmes' biopharma portfolio in key therapeutic areas such as vaccine and infectious diseases, ophthalmology, CNS, rare disease and cell and gene therapy among others.
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Responsible for successful delivery of biostatistics and statistical programming services to Emmes biopharma clients overseeing budget, timelines, and quality of biostatistics related deliverables.
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2022-27072 North Carolina United States North Carolina, United States Field Service/Support Bio-Rad is looking for a Field Service Engineer who will perform repairs, upgrades, and preventive maintenance on our instruments for clinical diagnostics, life science, and biopharma customers based in Raleigh, NC traveling 50-70% daily local tra.
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Minimum of 10 years experience in a business development role for pharma/biopharma/biotechnology. Collaborate with internal teams (e.g., marketing, product development, regulatory affairs) to ensure alignment of business development strategies with company goals.
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Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
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Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. The Senior Computerized Systems Validation Engineer, under general direction, will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.
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Preferred Two (2) years of recent leadership or progressive supervisory experience required Prior experience supervising and managing Quality Assurance/Improvement staff 5+ years of experience with pharmacy quality & regulatory 5+ years of experience within biopharma, pharmacy quality health system, or other pharmacy related background preferred.
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Familiarity with Veeva or other Regulatory platforms in BioPharma. In this vital role you will will work with our Research and Development (R&D) Digital Technology and Innovation (DTI) group supporting R&D’s Global Regulatory Affairs & Strategy (GRAAS) function in alignment with our business and DTI strategy.
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At least ten years of biopharma experience with five years of relevant regulatory experience at a leadership level in the field of gene therapy. The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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The Biologics Virus Clearance Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.
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Work with the Agile Team, Product Owner, Release Train Engineer, and Scrum master to plan and execute work. Experience with AWS services: EC2, S3, EMR, RDS, Redshift/Spectrum, Lambda, Glue, Athena, API gateway, and design patterns (Containers, Serverless, Docker, etc.
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Cultivate engagements between Danaher and biopharma key opinion leaders (KOLs) in hematology and related disease areas; possess in depth knowledge of biopharma drug pipelines in hematology and anticipate the diagnostic needs of pharma (from Research Use Only (RUO) to Clinical Trial Assay (CTA) to In Vitro Diagnostics (IVD) inclusive of Companion Diagnostics (CDx) and Lab Developed Tests (LDTs.
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Identify new research opportunities beyond the OpCo or Platform core R&D efforts and support strategic IP management, as well as guidance around FDA and international regulatory matters, partnering with Platform and OpCo legal counsel.
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Catalent Pharma Solutions in Kansas City, MO is hiring a Storage and Receiving Associate II. This role supports clinical trial projects, ensuring that all work carried out is in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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