Senior GMP Technician, Downstream

Forge Biologics•Columbus, OH

10d•Onsite

About The Position

We are seeking an experienced and highly skilled individual to join our Downstream Manufacturing team. As a Senior Technician, GMP Manufacturing - Downstream you will play a pivotal role in the purification and processing of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. Your expertise in downstream bioprocessing and strong leadership abilities will contribute to the success of our manufacturing operations and the delivery of cutting-edge gene 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).
Prior experience working in a GxP or regulated environment.
Downstream processing or biologics manufacturing experience.
Extensive expertise and hands-on experience with downstream processing techniques and equipment, such as chromatography systems, filtration systems, centrifuges, and TFF systems.
Proficiency in conducting in-process testing and quality control checks to ensure product quality and compliance.
Excellent attention to detail and ability to accurately document and record experimental data and manufacturing activities.
Strong organizational skills and the ability to manage multiple tasks, prioritize effectively, and meet project timelines in a fast-paced environment.
Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
Demonstrated leadership abilities, including experience in mentoring and training junior team member.
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

Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

Responsibilities

Lead and execute 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.
Independently prepare, operate, and troubleshoot advanced downstream equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring optimal performance and compliance.
Monitor critical process parameters during manufacturing operation, analyze data, and proactively identify and address deviations or abnormalities, ensuring timely reporting and resolution.
Perform in-process testing and quality control checks, such as pH, conductivity, pressure measurements, and other analytical techniques to ensure product quality and compliance with specifications.
Lead and document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
Collaborate closely with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents, ensuring compliance with regulations and meeting production timelines.
Drive process improvements by evaluating new technologies, equipment, and methods, and leading the implementation of strategies to enhance manufacturing efficiency, productivity, and compliance.
Mentor and train junior team members, providing guidance on process execution, troubleshooting, and adherence to cGMP guidelines.
Ensure the highest standards of safety procedures and environmental health and safety guidelines are followed, maintaining a safe working environment.
Stay updated with the latest advancements in gene therapy downstream manufacturing processes, regulatory requirements, and industry trends, and actively contribute to the continuous improvement of manufacturing practices.

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