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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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Demonstrated hands-on method development experience with Size Exclusion, Reverse Phase, Ion-Exchange, Capillary Electrophoresis and/or biological assays within drug development areas of the Biopharmaceutical Industry.
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Strong biopharmaceutical drug discovery and development acumen across multiple disciplines. This role will partner with the Biopharmaceutical Sciences CGT team on a variety of strategic, operational, and organizational matters across three pillars: CMC Project Leadership, Project Management and leadership team (LT) operations.
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The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world's poorest populations, diseases that combined cause five deaths every minute.
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Bristol Myers Squibb is an integrated global biopharmaceutical company engaged primarily in the discovery, development, and commercialization of novel therapies in the areas of hematology/oncology, cardiovascular and inflammatory diseases through innovative small molecule, biologicals and cell therapy approaches.
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Prior experience in large scale late phase Solid Tumor Oncology drug development and regulatory submissions (NDA, MAA, JNDA) with proven ability to lead multiple highly complex and/or high priority projects.
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Zymeworks is a publicly listed (NASDAQ:ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.
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Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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Minimum of 2 years of biopharmaceutical oncology or hematology sales experience. Key activities include promoting all assigned products to targeted oncologists, hematologist/ oncologists and ancillary staff, working with reimbursement and office management to ensure product reimbursement, in-servicing all staff to ensure safe and appropriate drug administration, driving thought-leaders and advocate development, and building strong relationships with other key personnel to drive product sales.
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Proven track record of successfully delivering an IT strategy aligned to deliver business in an agile and exponentially growing life sciences organization (preferably, gene/cell therapy or biopharmaceutical.
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Strong knowledge of key pharmaceutical functions throughout all stages of product development, including Marketing (e.g., Market Research, Market Access), HEOR, Medical Affairs, Preclinical, Clinical, Regulatory, CMC (e.g. supply chain, drug delivery), etc.
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Strong understanding of U.S. FDA regulatory requirements for the development of Biotech/Biopharmaceutical drug therapies. Nova Biomedical, international and privately held company, is a world leader and innovator in biosensor technology.
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M.D. or D.O. degree with a minimum of 3 - 5 years of experience in oncology drug development in a biotechnology or pharmaceutical company. Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity.
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The ADC Chemistry (AC) group is seeking a highly motivated and creative synthetic chemist to develop novel payloads for antibody-drug conjugates (ADCs). Contemporary knowledge of the key Medicinal Chemistry concepts and design tools required for pharmaceutical drug discovery.
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