Bioprocess Specialist - CONTRACT

Job description

The Bioprocess Specialist II plays a critical role in the cell and gene therapy manufacturing processes at GeneFab. This position involves executing both upstream and downstream processes in a GMP-compliant cleanroom environment, with responsibility for troubleshooting, deviation management, training, and contributing to 5S and other improvement initiatives with the goal of ensuring on time delivery and right first-time execution of Manufacturing batches. You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes. ### Responsibilities: - Technical proficiency in aseptic techniques working with manufacturing equipment/instruments in open and closed systems - Organize, coordinate, and lead production activities and ensure execution of processes in production while strictly adhering to cGMP standards - Accurately complete batch records, forms, and documentation in line with Good Documentation Practices (GDP). - Work as part of a team to support the execution of daily GMP manufacturing activities. - Train staff in processing methods, aseptic technique, and cGMP clean room operations. - Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices. - Initiate and support the closure of Deviation Reports and CAPAs - Other duties as assigned by management. ### Qualifications: - Minimum High School diploma or equivalent experience is required. Associates or higher degree in Biology, Life Science, or Engineering is preferred. - 3-4 minimum years of experience in biotech or pharmaceutical manufacturing, preferably in a cleanroom environment. - Familiarity with cGMP standards and basic understanding of Good Documentation Practices. - Proficiency working in cGMP cleanrooms and aseptic techniques - Advanced understanding of pipetting and micro pipetting. - Demonstrated ability to identify, challenge, and implement potential improvements to work procedures. - Ability to work flexible hours, including nights and weekends, as schedules may shift in this start-up environment. - Ability to stand for extended periods and lift up to 20 pounds. - Strong communication and teamwork skills, with a willingness to learn.