Associate Scientist/Senior Associate Scientist, Process Development - Upstream

Company Overview:

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company.  Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality.  Forge has a 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters.  The Hearth is the home of a custom-designed cGMP facility dedicated to viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.  By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. 

Role Description:

We are currently seeking an Associate Scientist/Senior Associate Scientist, Process Development - Upstream to join the Forge Biologics team. This is an exciting opportunity to assist in the execution of laboratory experiments and protocols for upstream process development efforts. The candidate will assist in process development protocols/studies to optimize procedures for unique viral vector platform process and to assist in the transfer of client programs. The Associate Scientist/Senior Associate Scientist will work to meet production goals, notify management of any potential delays in the schedule, and make recommendations to resolve the issues.

This position reports to the Scientist II, Process Development - Upstream and is responsible for laboratory stocking, inventory management, and assisting in laboratory activities. This includes preparing growth media, chemical buffers, solutions or other reagents that involve the mixing of subcomponents and preparing raw materials for use in production steps. Work activities may also include performing laboratory techniques (cell culture, vector purification) in support of production of viral vectors. It is expected that this individual will work as a member of the development team while accomplishing the timely completion of assignments and reporting of unexpected technical issues. 

Responsibilities:

• Maintain cell growth, transfection, and infection of mammalian and insect cells for viral vector manufacturing using shake flasks and single-use bioreactors
• Culturing cells, performing transfections and/or infections with seed vectors, harvesting and lysing cells, and purifying vectors using density gradients, FPLC, or other techniques
• Assist in the downstream purification technologies related to recombinant viral vector purification using chromatography (affinity and ion-exchange) and filtration processes including microfiltration, depth filtration, tangential flow filtration, and sterile filtration
• Compile experimental data with minimal oversight and contribute results for publications or reports
• Support internal process transfer activities from Process Development to GMP
• Assisting in the authorization and review of research studies, along with the compiling of experimental data
• Prepare sterile reagents as dictated by procedures or management by filtration or steam autoclaving
• Reports any discrepancies from protocols/study procedures or any materials preparation problems to management

Requirements:

• Master’s degree in Biology, Chemistry, or relevant area; Bachelor’s degree with 2+ years of relevant experience may be considered
• Technical proficiency required for aspects of cell line growth and production of biological product
• Broad understanding of cell culture techniques is required; experience with bioreactors is highly preferred
• Working knowledge of downstream purification techniques is preferred
• Experience with production of biologics and performing bioassays is preferred
• Working knowledge of cGMP requirements is preferred
• In our commitment to safety of our employees and customers a COVID vaccination and booster is required.