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Role Summary
Sr. Associate, Manufacturing (Grave Shift) responsible for shift-based operations supporting large-scale solutions (buffers and media), material inventory, and process equipment in Upstream or Downstream areas, ensuring compliance with cGMP, SOPs, licenses, and safety practices. Requires shift work including weekends, off hours, and holidays.
Responsibilities
- Operate large scale bioprocess equipment for Cell Culture, Purification, or Buffer and Media processing
- Perform all aspects of processing with a broad understanding of science, compliance, and technical aspects
- Demonstrate competency with process equipment and automated control systems
- Perform cleaning and sterilization of parts and equipment used in manufacturing
- Knowledge of biotech manufacturing processes and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations
- Understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate
- Ensure compliance; adherence to SOPs, batch records, good documentation practices, and data capture
Qualifications
- Required: Bachelorโs degree in science or engineering or associate degree in science or Biotech certificate with 2+ years of experience in biotech manufacturing or other regulated industry
- Preferred: 4 years of college or 2 years biotechnology program
Skills
- Strong verbal and written communication
- Teamwork with good conflict resolution and collaboration
- Initiative to identify areas for improvement and implement solutions
Education
- Bachelorโs degree in science/engineering or related field OR associate degree/biotech certificate with relevant experience
Additional Requirements
- Work environment may include strenuous, repetitive work with physical movements such as bending, reaching, climbing stairs and ladders, kneeling, and equipment connections
- Ability to lift/push/pull items regularly, average weight ~25 pounds
- May work around loud equipment and must use personal protective equipment; shift-based/off-hours work required