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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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Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls.
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Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. 10+ years of experience working directly in regulatory CMC or in a relevant technical development discipline, such as process development, analytical development, or quality assurance, including at least 6 years' experience directly in CMC regulatory.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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Whether you will spend your day in an office cubicle, operating a crane or running the melt shop at one of our mills, at CMC, you'll get the training and support from your team that you need to excel in your role and reach your full potential.
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Certified Municipal Clerk Program (CMC) designation or enrollment. Certified Municipal Clerk (CMC) by International Institute of Municipal Clerks. Principles and practices of municipal government administration.
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The primary focus of this position will be to lead the Seattle-based CMC lab function which includes CHO cell culture manufacturing, protein purification, and biophysical characterization. Icosavax seeks a Director, Translational CMC with a strong background in large molecule process development and analytical development to advance our vaccine programs.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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The role of a Psychiatric Mental Health Nurse Practitioners (PMHNP) at CMC of PA is to provide direct one-on-one high quality counseling, medication evaluation and management, to a range of clients with mental health diagnoses.
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If you're ready to reimagine ways to make the steel industry more sustainable, reinforce the bridges and roadways connecting our communities, and do meaningful work, you're ready to join CMC. Apply today and start moving your career - and our world - forward.
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The Associate Director Regulatory Affairs CMC is responsible for CMC regulatory support to enable clinical development, marketing authorization, manufacture and distribution of clinical supplies and commercial products.
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Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans. Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and R&D.
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The Sr Scientist II, Analytical Development, Biologics CMC will support the CMC analytical development for multiple types of biologics including but not limited to antibody-drug conjugates (ADC), monoclonal antibodies and bispecifics.
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The successful candidate should have strong expertise in immuno-oncology and will be focused on focus on the development of fit-for-purpose CMC assays using flow cytometry and cell-based immunoassays, to characterize engineered TCR-T cell drug substance and drug product.
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