GMP Technician II, Upstream

Forge Biologics•Columbus, OH

6d•Onsite

About The Position

Technician II, GMP Manufacturing - Upstream will be hands-on in the production and cultivation of AAV-based gene therapy products, ensuring compliance with cGMP regulations every step of the way. This is an exciting opportunity to utilize your expertise in upstream bioprocessing and contribute to the manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

Requirements

Bachelor’s Degree in Biology, Biochemistry, Biomedical Engineering or related field (or equivalent experience).
Experience working in a GxP or regulated environment.
Hands-on experience with cell culture techniques, bioreactors, centrifuges, filtration systems, and other upstream processing equipment.
Skilled in aseptic techniques, media and buffer preparation, and upstream analytical methods.
Detail-oriented with strong documentation and data recording skills.
Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
Experience and ability to mentor and train junior team members.
Ability to work flexible hours, including evenings, weekends, and holidays to support manufacturing production schedules.
Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

Nice To Haves

Prior cGMP manufacturing experience.
Upstream bioprocessing or biologics manufacturing experience.
Familiarity with viral vector-based gene therapy processes and quality requirements.

Responsibilities

Execute and oversee upstream manufacturing operations, including 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 proper calibration, maintenance, and troubleshooting when needed.
Perform complex media and buffer preparation, as well as the aseptic transfer of materials, adhering to cGMP guidelines.
Monitor process parameters during manufacturing operations, analyze data, and proactively identify and report deviations.
Conduct sampling and in-process testing, such as cell counts, viability, and metabolite analysis, and other analytical techniques, to ensure product quality.
Accurately document all manufacturing activities, data, and results in accordance with cGMP regulations and company policies.
Partner with Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents.
Support process improvement initiatives, including evaluating new technologies, equipment, and methods to enhance manufacturing efficiency, productivity, and compliance.
Mentor and train junior technicians, providing guidance on procedures and best practices.
Follow safety protocols and maintain a clean, compliant work environment.

Benefits

Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
A competitive paid time off plan
12 weeks of fully paid parental leave
Annual bonus opportunities for all full-time team members.
401(k) with company match
Special employee discounts, including childcare and dependent care savings.
Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer-paid short and long-term disability coverage
A fully stocked kitchen with free snacks and beverages
Ongoing professional development resources, training, and mentorship programs