GMP Technician I, Downstream

Forge Biologics•Columbus, OH

8h•Onsite

About The Position

As a Technician I, GMP Manufacturing - Downstream you will play a vital role in the production and purification 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

Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience).
Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
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.
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 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.
Downstream processing or biologics manufacturing experience.
Familiarity with purification techniques and equipment commonly used in downstream bioprocessing, such as chromatography systems, filtration systems, and TFF systems.
Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

Responsibilities

Perform routine downstream manufacturing operations, including but not limited to chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, according to Standard Operating Procedures (SOPs) and batch records.
Prepare and operate equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring they are properly calibrated and maintained.
Execute purification processes for AAV-based gene therapy products, 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.
Perform in-process testing and quality control checks, such as pH, conductivity, and pressure measurements, to ensure product quality and compliance with specifications.
Assist in the execution of process validation and technology transfer activities, collaborating with cross-functional teams to ensure successful execution and timely completion.
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