The Role
Execute upstream and downstream cell and gene therapy manufacturing in a GMP cleanroom. Perform aseptic techniques, complete batch records, troubleshoot deviations, support CAPA closure, train staff, and drive 5S/process improvements to ensure timely, right-first-time batch execution while collaborating with Operations, MSAT, Quality, and Facilities.
Summary Generated by Built In
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.
About GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.
We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
Skills Required
- High school diploma or equivalent
- Associate's or higher degree in Biology, Life Science, or Engineering
- 3-4 years experience in biotech or pharmaceutical manufacturing, preferably in a cleanroom environment
- Familiarity with cGMP standards and Good Documentation Practices
- Proficiency in cGMP cleanroom operations and aseptic technique
- Advanced pipetting and micropipetting skills
- Experience completing and reviewing batch production records and GMP documentation
- Ability to identify and implement process improvements (e.g., 5S)
- Ability to work flexible hours including nights and weekends
- Ability to stand for extended periods and lift up to 20 pounds
- Strong communication and teamwork skills; ability to train staff
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
GeneFab is a contract development, manufacturing, and synthetic biology biofoundry focused on cell and gene therapies. The company bridges innovation and manufacturing with end-to-end biotechnology services, combining computational design and data analysis with cGMP-compliant production to advance genetic medicines from concept to clinic, partnering with innovators to deliver life-changing therapies to patients in need.
