Scientist II, QC Analytical (2nd Shift)
Forge BiologicsColumbus, Ohio, United States · Posted 2 months agoDescription
Forge Your Future with Us:
At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.
Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.
What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.
At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.
If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.
About The Role:
Scientist II, Quality Control: This role combines hands-on analytical testing with leadership and oversight of QC staff. This position will ensure that testing is performed according to cGMP, regulatory requirements, and internal SOPs, while also fostering team development, managing daily workflows, and supporting continuous improvement. This role will also be responsible for advancing method development, validation, and troubleshooting efforts for gene therapy products.
Responsibilities:
Scientist II Responsibilities:
- Perform 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.
- Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay.
- Ensure the effective transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
- Contribute to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
- 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.
- Provide support for Deviations, Change Controls, and CAPAs related to in process and final product testing.
- Review and approve GMP documentation associated with in process and final product testing controls, including, but not limited to, Standard Operating Procedures (SOPs), Specifications, and Analytical Test Methods.
- Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.
- Compile data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.
- Draft and revise process documents, assay methods, and sampling plans.
- Support regulatory and client inspections and support internal audits of GMP systems as an SME.
Manager Responsibilities:
- Provide technical guidance and mentorship to direct reports and junior team members, promoting their personal growth and skill development.
- Assist/drive tracking and trending of in-process and final product testing data, including, but not limited to; leading/participating in out of specification (OOS)/out of trend (OOT) Laboratory Investigations.
- Responsible for performance appraisals and pay reviews of direct reports. Make decisions based on assigned objectives, as well as company policies and procedures.
- Participate in hiring process as assigned.
- Communicate updates proactively to Quality Control management and direct reports as needed.
- Perform review and approval (where appropriate) of laboratory data, methods, forms and investigations.
- Ensuring training for direct reports is driven to completion to support laboratory needs.
Qualifications:
- Bachelor's (or international equivalent) and/or 6+ years of relevant experience, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology) with demonstrated leadership skills.
- Advanced knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, ELISA).
Similar jobs
Est. 85,000 USD
Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from…
Est. 120,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 85,000 USD
Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from…
Est. 120,000 USD
At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to meas…
Est. 140,000 USD
Company: At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases o…
Est. 85,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 85,000 USD
At Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated. As an Adapter, you’ll have the opportunity t…
Est. 95,000 USD
Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from…
Est. 120,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 55,000 USD
COMPANY OVERVIEW Cresco Labs is one of the largest public, vertically integrated, multistate operators in the cannabis industry. Our portfolio of in-house cultivated and manufactured brands features some of the highest q…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 85,000 USD
At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to meas…
Est. 120,000 USD
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell thera…
Est. 140,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 140,000 USD
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, ta…
Est. 115,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 124,000 USD
About our Company: Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the d…
Est. 120,000 USD
About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, ta…
Est. 165,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 124,000 USD
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, p…
Est. 120,000 USD
GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-s…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 120,000 USD
Program Manager, Preclinical & Early Development Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines…
Est. 85,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 250,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 120,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
About Acadia Pharmaceuticals Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commerci…