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2) Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product and Supply chain plant operations.
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Our team has spent their careers in cardiopulmonary disease research, drug and aerosol development, commercialization and company building. Reporting directly to the Chief Commercial Officer, the VP of Commercial Operations will be responsible for leading the core functions of Market Research and Analytics, Forecasting, Sales and Marketing Operations, and Commercial Learning and Development.
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Professional Knowledge: Thorough understanding of diagnostic technologies, global regulatory frameworks, and biomarker applications in drug development. Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development.
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Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Develop and enforce operational standards for biomarker management, vendor relations, and internal processes to ensure program quality, efficiency, and regulatory compliance.
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In this vital role the Senior Counsel -R&D Regulatory will be responsible for legal support of Amgen’s Global Development organization, as well as Global Regulatory Affairs, Patient Safety, Medical Affairs, R&D Quality and Compliance, Precision Medicine, Drug Delivery, and other R&D functions.
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May collaborate with other partners and internal colleagues in various aspects of Gene Therapy drug discovery and development. Designs in vitro and in vivo strategies for development of Gene Therapies and conduct and/or manage in vitro and in vivo studies to measure potency and efficacy.
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Lead biomarker and pharmacokinetic planning, definition, and implementation, overseeing sample collection for early and late-phase clinical trials. Engage with external diagnostic providers and global regulatory agencies to establish CDx filing pathways and compliance strategies.
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A high-level understanding of integrated drug development of biologics and/or pharma compounds. #LI-HybridAt least 8 years of experience in the industry (Pharma, biotech, generics, over the counter, device, animal health, and/or vaccines) and demonstrated combined leadership in Quality, technical experience, in depth knowledge of cGXP and regulatory expectations, quality and compliance processes, operations and strategy in the biopharmaceutical industry.
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Winning Attitude / Maximum Results -Delivering high-quality staffing, consulting, and development solutions since 2005. Client is a research-based biopharmaceutical company founded in 1987.
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In this role, you will provide leadership and advice on the development of optimum regulatory strategies for drug development, product lifecycle management and portfolio management, particularly focused on emerging biopharmaceutical company customer goals in oncology.
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Education: PhD degree in Biology, Translational Medicine, or related life sciences areas. Skills: Fluent in both verbal and written communication in Chinese and English. Develop strategic plans to meet budgetary requirements and successfully integrate companion diagnostic assays into end-of-life trials.
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TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases.
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Conducting design review including specifications, procurement, fabrication management, and installation of equipment, facilities, and utilities related to the manufacture of biologics bulk drug substance including basic unit operations involving fermentation, cell culture and protein purification and related equipment.
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Integrate strategic regulatory & drug development support services into emerging biopharmaceutical company clinical trial offerings. Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
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Broad understanding of gene therapy and editing vector and drug product process and analytical development and a proven track record in CMC development for clinical stage programs.
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