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Scientist I, Quality Control

4 months ago

Columbus, United States Forge Biologics Full time
Job DescriptionJob Description

About Forge

Our 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. Our goal is simple but vital to patients living with disease, and we take it seriously. 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 Team

The 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 Role

The Scientist I, Quality Control (Analytical) will play an active effort in method development and validation. This position will take ownership of complex testing procedures, collaborating on strategic quality initiatives, and providing 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 provides an opportunity to play a significant impact in the success of client gene therapy programs.

What You'll Do

  • 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. May also represent QC as a 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.
  • 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.
  • 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, 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.

What You'll Bring

  • Bachelor'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.

Work Environment and Physical Demands

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

  • HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
  • OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
  • PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
  • ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

  • Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
  • Unlimited PTO (plus 14 paid company holidays)
  • Annual bonus for all full-time employees
  • Equity-incentive plan
  • 401(K) company match
  • Fully-stocked kitchen with free food/drinks
  • 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
  • Employee Assistance Program
  • Wellness benefits (financial planning services, mental health counseling, employer paid disability)
  • Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches