Analyst, Quality Control

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 Analyst, Quality Control (QC) to join the Forge Biologics team.  This is an exciting opportunity to help lead laboratory efforts and execute characterization testing and assays for Quality Control.  The candidate will optimize existing and implement new technologies and systems into Quality Control for research and GMP purposes.  The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

Responsibilities:

• Perform in process, release and stability testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories.
• Perform raw materials testing to ensure they conform to manufacturer specifications.
• Provide Biochemistry and/or Molecular Biological expertise for the Forge GMP facility.
• Execute the procedures designed to demonstrate safety efficacy, and purity of the drug products under evaluations.
• Perform technical writing, routine testing, and all other associated activities. 
• Responsible for training, sampling, routine testing, method qualification/validations, and investigations. 
• Adhere to all GMP requirements, maintains a solid understanding of FDA/EMEA regulations, and interacts/communicates with Quality Management. 
• Support the QC management team for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.
• May be responsible for upstream (cell culture and virus production) and downstream (harvest and purification) testing activities to support a singular “platform” process for the entire AAV program portfolio.
• Assist in sample coordination for contract testing, ensuring proper paperwork is completed shipping procedures are followed.

Requirements:

• Bachelor’s degree in biology, molecular biology, virology, biochemistry or related discipline with 0-4 years of related experience
• Experience and knowledge in the pharmaceutical and/or biotech industry in testing within a GxP environment is preferred
• Experience in qPCR, ELISA, Western Blot, Cell Culture, and immunoassays is preferred.
• Proficiency with Microsoft Office