GMP Technician

Job Title: GMP Lab Technician

We are currently seeking a GMP Lab Technician to join the Forge Biologics team. This is an exciting opportunity to contribute to and lead efforts in the execution of manufacturing life changing gene therapies for human use. The candidate will participate in GMP manufacturing campaigns and provide hands-on support for new technologies and systems in our GMP manufacturing facility. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

The GMP Lab Technician provides manufacturing and operational expertise for the Forge GMP facility in Grove City, OH. This will include technical writing, routine testing, and all other associated activities. The GMP Lab Technician responsibilities include, but are not limited to; training, sampling, manufacturing activities, method qualification/validations, investigations, and cleaning support. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, and effective interactions/communication with Operations Management. The GMP Lab Technician may also support the Operations management team for activities related to interviewing and training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The GMP Lab Technician may be responsible for performing the manufacturing and in- process sampling for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories. The GMP Lab Technician will execute the procedures designed to assure safety, efficacy, and purity of the drug products being manufactured. The GMP Lab Technician may be responsible for upstream (cell culture and virus production) and/or downstream (harvest and purification) manufacturing activities to support a processes for the entire AAV program portfolio.

Responsibilities:

• Performs manufacturing activities and sampling that incorporates application of GMP principles and methodologies.
• Supports thorough investigations to determine root cause of OOS investigations the implementation of appropriate corrective and preventative actions in a timely manner.
• Trains junior staff in laboratory skills and scheduling lab/equipment.
• Plans work to meet production and schedule requirements from clients (internal and external).
• Prepares data associated with manufacturing processes and transfer activities to clients. May serve as the Person-in-Plant (PIP) support during manufacturing campaigns.
• Supports internal process transfer activities and may serve as Subject Matter Expert (SME) to troubleshoot processes.
• Delivers results in a high paced environment.
• Supports packaging and shipping finished product and/or coordinates the effort.
• Additional responsibilities not listed may be assigned as needed by management.

Requirements:

• Minimum Bachelor’s Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
• Experience in a GMP or QC environment is preferred but not required
• 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 confined spaces and near operating equipment.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed.
• Travel on an infrequent basis is required (<5%) to support job responsibilities and commitments.
• In our commitment to safety of our employees and customers a COVID vaccination is required.

Special Knowledge or Skills Preferred:

• Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
• Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
• Knowledge of biopharmaceutical manufacturing process workflows.
• Knowledge in the following system(s): Cell Culture and Cell-based assays, Pharmaceutical Utilities, HPLC, Microbial testing, Mass spectrometry, AUC, PCR, ELISA, and gel electrophoresis.