Upstream GMP Tech I — Gene Therapy Manufacturing

Drive Capital

Columbus (OH)

On-site

USD 55,000 - 75,000

Full time

14 days+

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Benefits offered by this job

Health insurance

Paid time off

Parental leave

Annual bonus

401(k)

Job summary

Forge Biologics in Columbus, OH is seeking a Technician I, GMP Manufacturing – Upstream. You will perform upstream manufacturing for AAV-based gene therapies, following cGMP and SOPs to support production and process development.

The role involves equipment operation (bioreactors, centrifuges, filtration), documentation, QA collaboration, and adherence to safety. Flexibility to work shifts and contribute to continuous improvement is required.

Qualifications

Associate’s or Bachelor’s degree in a scientific field, or relevant industry certifications; or high school diploma with +2 years of related experience.
Previous experience working in a regulated manufacturing or laboratory environment.
Excellent organizational skills and the ability to multitask in a fast‑paced environment while adhering to strict timelines.
Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders.
Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
Strong problem‑solving skills and ability to identify and elevate issues as needed.
Ability to adapt to changing priorities and work independently as well as part of a team.
Flexibility to work in shifts, including weekends and holidays, as required by manufacturing production schedules.
Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

Responsibilities

Execute upstream manufacturing operations, including but not limited to cell culture expansion, transfection, and harvest steps, according to Standard Operating Procedures (SOPs) and batch records.
Prepare and operate bioreactors, centrifuges, filtration systems, and other equipment required for upstream processing, ensuring they are properly calibrated and maintained.
Perform media and buffer preparation, as well as the aseptic transfer of materials, adhering to cGMP guidelines and maintaining a clean and organized work area.
Monitor critical process parameters during manufacturing operations and report any deviations or abnormalities to the supervisor in a timely manner.
Conduct sampling and in-process testing, such as cell counts, viability, and metabolite analysis, to ensure optimal culture conditions and product quality.
Document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
Collaborate with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents related to upstream manufacturing processes.
Participate in process improvement initiatives and support the implementation of new technologies, equipment, and methods to enhance manufacturing efficiency and productivity.
Follow safety procedures and adhere to environmental health and safety guidelines to maintain a safe working environment.
Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes.