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Experience with cell and gene therapy tech transfer, scale-up, validation, and commercialization. Lead the tech transfer, development, and optimization of manufacturing processes for advanced therapies, including cell culture, gene editing, downstream processing, fill/finish operations.
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Nuclear Medical Tech credentialed from the Nuclear Medicine Technology Certification Board (NMTCB) obtained prior to hire date or job transfer date. Radiologic Technologist specializing in Computed Tomography credentialed from the American Registry of Radiologic Technologists (ARRT) obtained prior to hire date or job transfer date.
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One or more of the following required: Nuclear Medical Tech credentialed from the Nuclear Medicine Technology Certification Board (NMTCB) obtained prior to hire date or job transfer date.
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One or more of the following required: Radiologic Technologist specializing in Radiography credentialed from the American Registry of Radiologic Technologists (ARRT) obtained prior to hire date or job transfer date.
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Works with cross functional team to facilitate NPI process fit; including batch record review, assistance with area engineer to ensure process fit within BU3 manufacturing suites, work with Tech transfer to produce standardized and efficient clinical batch record.
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Is responsible for facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.
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Required to earn the Board of Registered Polysomnographic Technologists (BRPT) Registered Polysomnographic Technologist (RPSGT) credential within 18 months of hire/transfer. Earn the American Board of Sleep Medicine (ABSM) Registered Sleep Technologist (RST) credential within 18 months of hire/transfer.
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Lead tech transfer activities as internal site transfers or transfers from client sites to BAM sites. Work closely with all departments, and other sites in developing an established checklist for proper tech transfer activities intra-site, but also inter-sites within the network.
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Responsible for all aspects drug substance including conjugation process development, validation, characterization, scale-up, tech transfer, analytical method qualification, specifications, release and stability testing.
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Tech transfer from lab to plant using sound process engineering principles of oligonucleotides, phosphoramidites, nucleic acid synthesis. Ph. D. in Chemistry, Organic Chemistry, Nucleoside Chemistry related discipline with minimum 2 years’ experience, preferably in oligonucleotide field.
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Supports BU3 metrics and help establish meaningful KPIs to identify and enable continuous improvement in tech transfer and new product introduction. Proficiency with tech transfer process and familiarity with equipment and facilities validation.
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Previous experience in cell culture scale-up, tech transfer including drafting development reports, production batch records, protocols and Knowledge of scale-up and scale-down models is highly desired.
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Support tech transfer of new methods from analytical development and contract laboratories to the Quality Control Laboratory. A PhD master’s degree in microbiology, Biochemistry, Chemistry, or Analytical Chemistry/Bioanalytical Chemistry is preferred.
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Basic knowledge of cell culture manufacturing principles, risk assessments (FMEA), Chemistry, Manufacturing, and Controls (CMC) principles, and tech transfer. GC Therapeutics’ equal employment opportunity policy applies to all terms and conditions of recruiting, hiring, placement, training, compensation, transfer, leave of absence, employment, promotion, layoff and termination of employment.
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A master's degree in microbiology, Biochemistry, Chemistry, or Analytical Chemistry/Bioanalytical Chemistry is required. Serve as an ADMA expert for Quality Control Chemistry, Bioanalytical, Raw Material, Microbiology, Stability, and Lab Support departments to support testing and ensure the highest level of product quality.
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