Forge Biologics Inc.
Scientist I, Quality Control (Analytical)
Forge Biologics Inc., Columbus, Ohio, United States, 43224
About ForgeOur mission at Forge Biologics is to enable access to life-changing gene therapies and help 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. 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 TeamThe Quality Control team is a dedicated group responsible for ensuring the safety and efficacy of our advanced gene therapies through rigorous analytical testing. Committed to adherence to regulatory standards, this team performs comprehensive testing on AAV gene therapy products, evaluating vector potency, identity, purity, and stability. With a focus on data integrity and continuous improvement, our QC team plays a crucial role in delivering high-quality products that positively impact patients' lives.About The RoleThe
Scientist I, Quality Control (Analytical)
will play an active role in method development and validation. This position will take ownership of complex testing procedures, collaborate on strategic quality initiatives, and provide technical guidance to junior staff. This role provides an opportunity for career growth as you gain experience in the evolving field of gene therapy. This role offers a chance to make a significant impact on the success of client gene therapy programs.What You’ll DoPerform in-process, release, and stability testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from PD, research, and GMP laboratories.Lead and perform advanced analytical testing quality control assays, including qPCR, ELISA, SDS-PAGE, Western blot, and HPLC, to assess the quality, potency, and safety of AAV vector products.Support internal process transfer activities and serve as Subject Matter Expert (SME) to troubleshoot processes/assays. May also represent QC as an SME during audits and inspections.Maintain detailed records of experimental procedures, outcomes, and observations following Good Documentation Practices (GDP).Contribute to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.Conduct thorough investigations to determine the root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.Schedule equipment maintenance, calibration, and qualification activities.Lead sample coordination for contract testing, ensuring proper paperwork is completed and shipping procedures are followed.Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.Compile data with minimal oversight, generate reports, and archive assay data; responsible for performing the analysis and interpretation of assay results.Draft and revise process documents, assay methods, and sampling plans.What You’ll BringBachelor’s Degree in Molecular Biology, Biotechnology, Biochemistry, or related field.Experience in mass spectrometry analysis in biological molecules.Advanced knowledge of HPLC, LC-MS and/or LC-MS/MS, as well as any of the following: cell-based assays, PCR, ELISA, SDS-PAGE, CGE, or molecular biology techniques.Experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on LC-MS, LC-MS/MS and HPLC.Proven ability to execute, troubleshoot, and optimize analytical assays.
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Scientist I, Quality Control (Analytical)
will play an active role in method development and validation. This position will take ownership of complex testing procedures, collaborate on strategic quality initiatives, and provide technical guidance to junior staff. This role provides an opportunity for career growth as you gain experience in the evolving field of gene therapy. This role offers a chance to make a significant impact on the success of client gene therapy programs.What You’ll DoPerform in-process, release, and stability testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from PD, research, and GMP laboratories.Lead and perform advanced analytical testing quality control assays, including qPCR, ELISA, SDS-PAGE, Western blot, and HPLC, to assess the quality, potency, and safety of AAV vector products.Support internal process transfer activities and serve as Subject Matter Expert (SME) to troubleshoot processes/assays. May also represent QC as an SME during audits and inspections.Maintain detailed records of experimental procedures, outcomes, and observations following Good Documentation Practices (GDP).Contribute to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.Conduct thorough investigations to determine the root cause of OOS investigations and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.Schedule equipment maintenance, calibration, and qualification activities.Lead sample coordination for contract testing, ensuring proper paperwork is completed and shipping procedures are followed.Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.Compile data with minimal oversight, generate reports, and archive assay data; responsible for performing the analysis and interpretation of assay results.Draft and revise process documents, assay methods, and sampling plans.What You’ll BringBachelor’s Degree in Molecular Biology, Biotechnology, Biochemistry, or related field.Experience in mass spectrometry analysis in biological molecules.Advanced knowledge of HPLC, LC-MS and/or LC-MS/MS, as well as any of the following: cell-based assays, PCR, ELISA, SDS-PAGE, CGE, or molecular biology techniques.Experience with the analytical methods used for gene therapy in-process testing, release testing and characterization, with an emphasis on LC-MS, LC-MS/MS and HPLC.Proven ability to execute, troubleshoot, and optimize analytical assays.
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