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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API.
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This individual is a critical member of the Biomanufacturing team and will oversee all biologics cGMP clinical manufacturing activities including, technology transfer, upstream cell. Transfers and Introduces technology of cell therapy-based and therapeutic protein processes into manufacturing collaborating extensively with Scorpion’s Process Development group to develop cGMP-compliant, clinical-scale production processes.
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A dynamic program manager with deep knowledge of the drug discovery and development process, including demonstrated experience with leading programs through preclinical development and regulatory submission, with a strong preference for early clinical development experience with biologics development and product candidates in immunology.
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Essential Functions Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners.
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Responsibilities: Provide leadership and direction to the Biologics Cell Culture organization, a department of scientists and engineers Accountable for development and characterization of robust cell culture processes to support Pivotal clinical and Commercial manufacturing, including Life Cycle Management.
$274,635 - $355,410 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partner with cross functional members across Gilead Pharmaceutical Development & Manufacturing (PDM), including Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance and Technical Development to ensure successful commercialization of the late-stage portfolio, as well as on time delivery of clinical and commercial product.
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Knowledge and experience with HCP Elisa, Residual DNA testing, Protein A testing, method development for biologics, and method validation and transfer. This is a support role for commercial and clinical programs, including lab work, office work, teleconferencing, computer work, and running/attending meetings.
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Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
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The individual will play a hand-on execution role in the routine operation of the Biological pilot plant whose purpose is to produce material for preclinical, clinical, and commercial biologics drug substance to support Clients pipelines.
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The successful candidate excels in a collaborative, cross-functional, matrix team environment to enable the development of new drug products for pharmaceutics, biologics, and emerging modalities such as, but not limited to, antibody-drug conjugates, gene therapy, oligonucleotides, and SiRNA nanoparticulate delivery.
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Work collaboratively with process development leadership to develop and/or optimize cell therapy platforms (T cells and Stem cell therapies), to support Novartis Cell Therapy's multi-product portfolio of clinical development programs.
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Lead development and validation of Immunoassays, cell-based assays, and/or flow cytometry as required, to detect/monitor biologics in clinical and preclinical studies associated with drug development.
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In collaboration with AbbVie About the Role: Plays a key leadership role in developing our in vitro and in vivo strategies towards target identification and drug discovery, through to clinical candidate selection.
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Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Advancing products from clinical development to commercial launch.
$87,400 - $116,600 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Our state-of-the-art pilot plant is at the forefront of producing materials for preclinical, clinical, and commercial biologics drug substances, supporting our commitment to advancing healthcare worldwide.
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