full-time part-time employee contract
We are currently seeking a Quality Control (QC) Technician to join the Forge Biologics team. This is an exciting opportunity to lead the 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.The QC Technician may be responsible for performing the in-process and release testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from the PD, research, and GMP laboratories, as well as raw materials, to ensure they conform to manufacturer specifications. The QC Technician will execute the procedures designed to demonstrate safety, efficacy, and purity of the drug products under evaluation.The QC Technician 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.Responsibilities:Conducts Environmental Monitoring/Microbiological, Chemistry, and/or Biochemistry testing (e.g., microbial testing, titering by PCR, etc.) that incorporates application of GMP principles and methodologies.Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.Drafts and revises process documents, assay methods, and sampling plans.Trains junior staff in laboratory skills and scheduling lab/equipment maintenance.Plans work to meet production and schedule requirements from clients (internal and external).Prepares and presents data associated with manufacturing processes and transfer activities to clients. May serve as the Person-in-Plant (PIP) support during manufacturing campaigns.Reviews and trends QC data (environmental monitoring, microbiological, chemistry, and/or biochemistry) and publishes trend reports on a routine basis.Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay. May also represent QC as a SME during audits and inspections.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).Minimum 2 years’ experience in a Quality Control laboratory; GMP QC laboratory strongly 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 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.Special Knowledge or Skills Preferred.Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.Experience with an electronic Document Management System.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.