Scientist I, Quality Control (Proteins)

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

We are currently seeking a Scientist I, Quality Control (Proteins) to join the Forge Biologics team. This position in the Quality Control group will support analytical testing for Forge Biologic’s in-house programs as well as client projects. This individual will be responsible for the execution of analytical assays including, but not limited to, LC-MS, LC-MS/MS, HPLC, Sanger sequencing, NGS, protein and DNA gel electrophoresis and antibody-based detection such as ELISAs for evaluation of final and in-process gene therapy vectors.

What You’ll Do

• Execute analytical assays, primarily LC-MS, LC-MS/MS and HPLC, to characterize viral vector/gene therapy products, including in-process testing, in-process control, and lot release testing.
• Learn and perform other analytical assays such as DNA/RNA isolation, PCR, ELISA, SDS-PAGE, CGE and western blot.
• Work seamlessly with cross functional stakeholders including Process Development, Product Development, and Analytical Development to help advance the AAV vector production portfolios.
• Document assay results following cGMP/GDP compliance.
• Partner with the Analytical Development team to qualify and/or validate methods, assisting in assay optimization as applicable.
• Communicate data to Quality Management and reviewing the data of junior team members.
• Participate in tracking and trending of in-process and final product testing data including leading/participating in out of specification (OOS)/out of trend (OOT) laboratory investigations as SME for various analytical assays.
• Drive initiation and closure of Deviations, Change Controls, and CAPAs related to in-process and final product testing.
• Participate in regulatory and client inspections as needed, and support internal audits of GMP systems.
• Contribute to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, and justification of specifications.
• 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 as an SME.

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.

Preferred Skills

• Advanced Degree (Master’s or PhD) in Molecular Biology, Biotechnology, Biochemistry or related field.
• Experience in troubleshooting/maintenance of HPLC and mass spectrometers and optimization of LC/MS acquisition methods.
• Robust understanding of cGMP requirements as they pertain to Quality Control and Analytical Development testing.
• Experience in cell and gene therapy (e.g., AAV manufacturing).
• Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.
• Knowledge of CMC analytical and regulatory requirements.
• Experience with aseptic techniques in mammalian cell culture systems and performing bioassays.
• Small company and/or start-up experience.

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