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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.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Aseptic, Sterile Injectables, cGMP, Downstream, Fill finish, Gmp, Cleanroom, Laboratory, Contract Manufacturing, Compound, Compounding, batch processing, Autoclave, pharmaceutical manufacturing, pharmaceutical, gowning, Chemistry, Sop, Batching, Aseptic technique, Quality assurance, Inspection, Sanitization, Batch record.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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). 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.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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Prior experience with batch record review and releasing batches. Responsible for compliant, thorough, and accurate batch review activities, including QC analytical data and other ancillary batch documentation.
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Coordinate completion of batch record review in a timely manner to support clinical product availability. Batch Record Review: Perform batch record review. The Senior QA Specialist - GMP Manufacturing, is responsible for supporting quality operations during GMP clinical manufacturing of bioengineered organs at Miromatrix.
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Experience with PAS X (Korber) software for electronic batch records with detailed understanding of editing and validationStrong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessingDemonstrated ability to work in a teamDegree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Bachelor’s degree in a Scientific, Engineering or Biotech field with 4 years’ experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance. HS Diploma or Associate’s Degree with 5– 6 years’ experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.
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Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP's. Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.
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The Secondary Loop Process Control Engineer provides technical leadership and automation support of manufacturing operations in accordance with appropriate Good Manufacturing Practices (GMP) and safety guidelines.
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Demonstrated background in support of GMP Quality management systems, Conduct batch record review for clinical and commercial product manufactured for Humacyte. Background in one or more specialties of biotechnology: bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, cell biology, chemical engineering, and/or biochemical engineering.
$80,000 - $81,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Create, review and approve GMP related documentation including but not limited to SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, protocols, etc.
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Relevant industry experience in CMC-related scientific writing, QC activities and processes in a regulated (GMP-compliant) environment including batch production records, manufacturing procedures.
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At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelors Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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This individual will work with internal and external organizations to author batch documentation (i.e. Master Batch Records), author SOPs/Work Instructions, assist with process fit to plant analysis, facilitate process risk assessments, and other activities required to support GMP operations stand-up.
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