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Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. Lead Process Analytical Market development.
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Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. Build standard work and management dashboards to assess, lead and communicate operational and strategic performance of the HR function, adopting our culture of continuous improvement through our PPI (Practical Process Improvement) Business System.
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As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
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BA/BS in a scientific field relevant to the drug development process. ·Good understanding of FDA and EMA drug development and approval process. ·Comprehensive understanding of the overall drug development process.
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A thorough understanding of scientific methodology, clinical data, all phases of the drug development process and the interdependencies between Clinical Development and other functional areas (e.g., CMC, Nonclinical/Toxicology, Regulatory Affairs, etc.
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Arcmed offers labware and chromatography components to scientific laboratories in drug discovery and downstream biotech development workflows. Work with various Engineering groups or QA Manager to develop and execute plans including quality plan, risk management, Process Failure Mode and Effects Analysis (PFMEA), control plans, production part approval process (PPAP), part qualification checklist (PQC.
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Pharmaron is a premier contract research organization that offers a broad spectrum of R&D and manufacturing service capabilities throughout the entire drug discovery, preclinical, clinical development and commercialization process.
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Ability to quickly gain an understanding of the overall drug/vaccine development process and key functions involved. Independently manage development projects of any type, including those which require experience with drug / vaccine / biologics development, the Client organization and Client processes and procedures related to development teams due to their significant importance to the company or complexity.
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Responsibilities of the position include maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and Civica compliance requirements from the onset of facility start up to a successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
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Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry. Serving as a scientific communications and publications ambassador to the cross-functional team and business partners and ensuring production and adoption of publications and communication platforms, that best position McKesson as a thought leader in the space.
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Responsible for representing GRA in the GPT (Global Project Team) as well representing the project team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Experience in providing regulatory strategic input into the Oncology drug development preferred.
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A minimum of 4 years of experience in biopharma/process development environment. Conduct literature and database research for material needed for scientific programmatic needs. Familiarity with general scientific/biotechnology laboratory supply requirements.
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Amgen is currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group at Cambridge, MA. Amgen’s DSTS group within Process Development (PD) is responsible for the invention and development of drug substance manufacturing processes and technologies to advance Amgen's exciting portfolio of synthetic and hybrid assets.
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This role will be the critical clinical and data partner for business development, marketing, and partnerships team members to anticipate biopharma, healthcare practitioners and payers needs in the space.
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The leader will drive the development of highly productive robust commercial fed-batch and perfusion processes leveraging strong scientific principles in medium development, cell metabolism, bioreactor engineering, and design of experiment.
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