GMP Technician I, Upstream

Forge Biologics•Columbus, OH

3d•Onsite

About The Position

We are seeking a detail-oriented and highly motivated individual to join our GMP Manufacturing, Upstream team. As a Technician I, GMP Manufacturing - Upstream you will play a critical role in the production and cultivation of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. This position offers an exciting opportunity to contribute to the development and manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

Requirements

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 escalate 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.

Nice To Haves

Prior experience working in a cGMP manufacturing environment.
Upstream bioprocessing or biologics manufacturing experience.
Familiarity with cell culture techniques, bioreactors, centrifuges, and filtration systems
Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

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.

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