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Just - Evotec Biologics' Bioreactor Process Development group is seeking an enthusiastic and hardworking team member who is passionate about expanding worldwide access to biotherapeutics through the advancement of continuous bioprocessing technology and mammalian cell culture processes.
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Experience working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities). This person will join a fast-paced, collaborative, and multidisciplinary team to support bioreactor process development (perfusion and intensified fed-batch) at the bench and pilot scale for the advancement of low-cost biotherapeutics manufacturing.
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Is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. This person is responsible for the governance of the GMP facility environmental monitoring and contamination control program including the qualification of the GMP facility and maintaining the qualified status, aseptic process simulation, disinfection procedures/practices, disinfectants qualification, cleaning validation, and oversight of microbiological testing of raw materials, intermediates, drug substance, and finished goods.
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The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing.
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Extensive expertise in U/HPLC, CE, SDS-PAGE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Working knowledge of lyophilization cycle development, GMP drug product fill and finish, lab automation, data science, and knowledge management. Extensive experience with formulation development and tox/clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats, in a wide concentration range from ultra low to high; experience of IND and/or BLA filings.
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5+ years’ experience in GMP Quality or Manufacturing in biopharma/biologics/pharma industry. We are looking for a Manager/Senior Manager of Quality Operations to help provide quality oversight for our biologics commercial and clinical development programs.
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Perform batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigation. 5+ years of experience in Quality Assurance with demonstrated leadership skills, and a strong focus in GMP Quality.
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Proven track record of analytical development leadership for biologics and small molecules, experience with vaccines, carbohydrate, or conjugates is a plus. Experience in protein characterization by using different analytical approaches, such as aggregates by SEC-LC, charge variants by AEX, HCP by CE-SDS, peptide mapping and intact mass analysis by LC/MS/MS, and protein quantitation by SoloVPE and other colorimetric assays.
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Key Words: Analytical Development | Method Development | Assay Development | MDV | Protein Characterisation | Product Characterisation | Protein Analysis | AAV | Viral Vector | Gene Therapy | GMP | QC | Quality Control | CMC | Biologics | Biopharmaceutical | C> | ATMP.
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The Vice Preside of CMC Radiopharmaceutical Process Development will provide oversights to cell line development, antibody process development and scale up, conjugation and radio drug substance and drug product development and GMP manufacturing.
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Knowledge of Good Manufacturing Practices (GMP), Quality System Regulation (QSR) and International Organization for Standardization (ISO) We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system.
$28 - $30 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Experience with Preclinical to commercial product development and experience in biologics preferred. Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
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Reporting to the Associate Director of GMP Quality Operations, the Manager/Senior Manager of GMP Quality Operations will provide day to day quality support to the various Arcellx GMP-relevant functions and will be responsible for the administration of quality standards, internal practices and continuous improvement as it relates to internal technical operations and collaborations with manufacturing vendors.
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Knowledge of GMP/GTP regulations for pharmaceutical or biologics manufacturers and/or blood bank establishments. The Quality Management Specialist will be responsible for ensuring adherence to the applicable regulations and standards (e.g., GMP, GTP, AABB, FACT, CAP, JCO.
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