Senior Associate Scientist II, Process Development - Downstream

About Forge: 

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. 

 

Job Title: Senior Associate Scientist

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.

Qualifications:

• 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.

Physical Requirements:

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. 

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities an