QC Molecular Biologist

Role Description:
We are currently seeking a QC Molecular Biologist to join the Forge Biologics Quality Control (QC) team. This is an exciting opportunity to help 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 Molecular Biologist provides Molecular Biological, Biochemical, and Microbiological expertise for the Forge GMP facility in Grove City, OH. This will include technical writing, routine testing, and all other associated activities. The QC Molecular Biologist responsibilities include, but are not limited to; training, sampling, routine testing, method qualification/validations, and investigations. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, and effective interactions/communication with Quality Management. The QC Molecular Biologist may also 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.

Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The QC Molecular Biologist 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 Molecular Biologist will execute the procedures designed to demonstrate safety, efficacy, and purity of the drug products under evaluation. The QC Molecular Biologist 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. As a member of the QC team this position will support Forge Biologic's in-house programs as well as client programs. You will be responsible for the execution of molecular assays including, but not limited to, qPCR, Sanger sequencing, NGS, ELISAs, protein and DNA gel electrophoresis, and cell-based and immunoassays supporting the gene therapy quality organization.

Responsibilities:

• Performing product characterization related assays in support of release and characterization, method development/optimization, methods transfer, and analytical support for the manufacture of gene therapy products. Analytical support includes, but is not limited to DNA/RNA isolation, qPCR, RT-qPCR, ddPCR, ELISA, SDS-PAGE and Western Blot that incorporates application of GMP principles and methodologies.
• Compiling data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.
• Maintain detailed, up to date, and reviewed laboratory notebooks (either paper-based or electronically).
• 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.
• Apply relevant scientific principles and techniques to analytical testing problems.
• 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).
• 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.
• Additional responsibilities not listed may be assigned as needed by management.

Requirements:

• Bachelor's degree in biology, molecular biology, virology, biochemistry or related discipline and 6 years of relevant experience in a pharmaceutical, biotechnology or related environment, OR
  Master's degree in these same disciplines and a minimum of 4 years of relevant experience in these same disciplines, OR
  Doctorate degree in these same disciplines.
• Excellent verbal and written communication skills.
• Ability to work with a high attention to detail.
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to work flexible hours necessary to support production and/or product transfer activities.
• In our commitment to safety of our employees and customers a COVID vaccination is required.
• Travel on an infrequent basis is required (5%) to support job responsibilities and commitments.

Special Knowledge or Skills Preferred:

• • Proficiency with the conduct of qPCR, cell-based assays, and immunoassays is preferred
  • Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization is 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, Cell-based assays, Pharmaceutical Utilities, HPLC, LC/MS, Microbial testing and identification, Mass Spectrometry, AUC, qPCR and ddPCR, ELISA, gel electrophoresis.