Analyst I, Quality Control (Raw Materials)

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.  

 

About The Role  

We are currently seeking an Analyst I, Quality Control (Raw Materials) to join the Forge Biologics team. In this role, you will be responsible for conducting testing and evaluation of raw materials used in AAV vector production. Your work will involve executing various analytical tests per the processes defined within SOP documents in a cGMP compliant manner. Additionally, you will be responsible for performing comparisons between measured results and expected criteria and communicating those comparisons in a timely and thorough way. Your contribution will be essential in maintaining the integrity and safety of our gene therapy products.

What You'll Do:

• Inspect all materials that arrive at the facility for integrity and quality.
• Communicate between departments to ensure operations all have all required inspected materials.
• Perform routine testing and analysis of raw materials using established protocols and analytical methods.
• Conduct a range of tests, including but not limited to identity, purity, potency, and microbial contamination, on incoming raw materials.
• Accurately document test results, observations, and procedures in accordance with Good Documentation Practices (GDP).
• Collaborate with the procurement team to ensure timely receipt and testing of raw materials.
• Escalate any non-conformance or deviations to appropriate channels for investigation and resolution.
• Assist in the development and optimization of new testing methods and procedures.
• Contribute to the maintenance, calibration, and qualification of laboratory equipment.
• Adhere to Standard Operating Procedures (SOPs), cGMP guidelines, and regulatory requirements.
• Maintain a clean and organized laboratory environment and adhere to safety protocols.

 

What You'll Bring:

• Bachelor’s Degree in Biology, Biochemistry, Chemistry or a related discipline.
• Familiarity with basic laboratory techniques and analytical methods.

Preferred Skills:

• Prior experience in a laboratory or quality control environment.
• Understanding of cGMP and regulatory guidelines.
• Prior experience in a laboratory or quality control environment.
• Understanding of cGMP and regulatory guidelines.

 

Work Environment and Physical Demands  

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 and activities may change or new ones may be assigned. 

Forge Biologics is an equal opp