Associate/Senior Associate Scientist, Process Development - Downstream

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 AAV 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. 

Job Overview

We are currently seeking an Associate/Senior Associate Scientist, Process Development - Downstream to join the Forge Biologics team.  This is an exciting opportunity to assist in the execution of laboratory experiments and protocols for downstream 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/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 Director, Process Development - Downstream 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 (vector purification and cell culture) in support of production of recombinant adeno-associated virus (rAAV) vectors. It is expected that you will work as a member of the development team while accomplishing the timely completion of assignments and reporting of unexpected technical issues.

Job Duties/Responsibilities

• Assist with overall maintenance of the production and testing facilities.  This includes but may not be limited to performing quality systems checks, buffer preparation, autoclaving of media, packing of biohazard material, monitoring or sanitizing equipment, preparing facility for production campaigns, and periodic cleaning of incubators, centrifuges, FPLCs, biological safety cabinets (BSCs), and other equipment
• Culturing cells, performing transfections and/or infections with seed vectors, harvesting and lysing cells, and purifying vectors using density gradients, FPLC, or other techniques
• Provide support in the receipt and distribution of incoming raw materials for research, preclinical, and clinical manufacturing
• Unpack reagents, maintaining proper cold storage, restock supplies in storerooms or laboratories
• Quarantine and prepare incoming raw materials intended for preclinical or clinical manufacturing for inspection and release
• Assist in maintaining proper inventories of raw materials and consumables
• Prepares formulations and raw materials as specified in protocols without the introduction of contaminants
• Prepare sterile reagents as dictated by procedures or management by filtration or steam autoclaving
• Maintains clean work environment in all work areas
• Reports any discrepancies from protocols/study procedures or any materials preparation problems to management
• Delivering results in a high paced environment
• Package and ship finished product to clients in accordance with procedures and regulations
• Additional responsibilities not listed may be assigned as needed by leadership

Requirements

• Bachelor’s degree in Biology, Molecular Biology, Virology, Biochemistry or related discipline
• Practical experience with FPLC is required, ideally with lab, pilot, and large-scale systems
• Experience with other aspects of downstream purification (e.g. – clarification/filtration, TFF, etc.)
• Experience with purification of vaccines or viral vectors is preferred
• Experience with production of biologics and performing bioassays is preferred
• Must be self-motivating, organized and proactive
• Strong technical aptitude including demonstrated experience in applying scientific reasoning to solve complex problems
• Ability to work hours necessary to support production and/or product transfer activities.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and cleanroom gowning attire as needed
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