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Downstream/Upstream Processing Technicians
2 months ago
Downstream/Upstream Processing Technician
Direct Hire
Kelly Science & Clinical is currently recruiting for a several Downstream & Upstream Processing Technicians with biomanufacturing company in San Antonio, TX.
Job Responsibilities:
Supports daily manufacturing responsibilities for clinical and commercial manufacturing programs.
Executes and documents batch records in compliance with current Good Documentation Practices.
Revise and review SOPs, batch records, and other documentation to support manufacturing.
Microbial fermentation and/or Mammalian cell culture in Upstream/Downstream processing.
Upstream knowledge and experience with the following:
Bacterial fermentation and Mammalian single-use systems up to 1000L
Continuous flow centrifuges
Homogenization and depth filtration operations
Single-use temperature controlled mixing systems
Downstream knowledge and experience with the following:
Bench-scale to large-scale chromatographic (AKTA) and HPLC systems (Agilent)
Packing and evaluating columns
Drug substance bulk fill or vial fill and aseptic handling techniques
Support deviation and CAPA resolution with SME and quality teams.
Provide input and support to MSAT/PD during development and scale up activities as necessary.
Support facilities in ensuring proper functionality of the equipment calibration and preventative maintenance as part of the equipment control program.
Maintain company and client confidentiality
Communicate safety policies and goals and ensure team members adhere to facility safety policies.
Job Qualifications:
Requires an Associate’s, BS or MS from an accredited college or university with major coursework in a Scientific or Engineering discipline.
Experience working in a GMP manufacturing environment is essential.
Manufacturing processes in microbial systems is highly desirable.
Requires 4+ year (Associate’s), 3+ years (BS), 1+ years (MS) of biomanufacturing experience.
Requires a strong background in cGMP principles and Quality Management Systems.
Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, PowerPoint and Project.
Job Details:
Monday-Friday; 8am-5pm; Flexible to work overtime
Mammalian and Microbial experience preferred
Direct Hire
Competitive salary
Downstream/Upstream Manufacturing
Relocation Assistance
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