Now Hiring - Senior Scientist, Process Development - Upstream in Columbus, OH

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 Upstream Process Development team is responsible for designing and optimizing the production processes of Adeno-Associated Virus (AAV) vectors, which are essential components in gene therapy treatments. The team focuses on developing scalable and robust upstream processes that enable efficient and high-yield production of AAV vectors. They conduct research and apply advanced techniques to enhance vector yield, quality, and purity, while also ensuring compliance with regulatory guidelines.

About The Role

We are currently seeking a Senior Scientist, Process Development – Upstream to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the laboratory experiments and protocols for upstream process development efforts. This candidate will be responsible for managing a team and overseeing the execution of process development protocols/studies to optimize procedures for unique viral vector platform process and to assist in the transfer or client programs.

What You'll Do (Responsibilities)

• Lead process development activities to design, optimize, and scale-up robust AAV production processes for gene therapy applications.
• Conduct experiments to evaluate and improve vector production efficiency, yield, purity, and quality attributes.
• Oversee and perform scalable maintenance, transfection, and infection of mammalian cell lines in shake flasks and single-use bioreactors.
• Collaborate cross-functionally with research and manufacturing teams to ensure seamless technology transfer and process implementation.
• Design and oversee execution of process development studies, including process characterization, optimization, and robustness evaluations.
• Analyze data generated during process development activities and utilize statistical tools to draw meaningful conclusions and make data-driven recommendations.
• Develop and execute process validation strategies and support regulatory filings.
• Identify and implement innovative technologies and methodologies to enhance process development capabilities and efficiency.
• Lead and mentor a team of junior scientists within the Process Development team, providing technical guidance and fostering a collaborative work environment.
• Author and review technical reports, standard operating procedures (SOPs), and other documentation required for regulatory compliance.
• Stay current with advancements in AAV production technologies, gene therapy field, and regulatory requirements, and apply this knowledge to continuously improve processes and support business growth.
• Lead development and tech transfer of internal and client programs as the process expert

What You'll Bring (Qualifications)

• Bachelor's degree in Chemical Engineering, Biochemistry, Biotechnology, or related discipline.
• Experience in upstream process development and scale up principles.
• Proficiency in the use of bioreactors utilizing mammalian or microbial cell lines.
• Demonstrated ability to lead and mentor a team, fostering collaboration, and delivering results in a fast-paced environment.
• Excellent analytical and problem-solving skills, with the ability to troubleshoot and optimize complex processes.
• Strong communication skills, both written and verbal, with the ability to effectively present scientific findings and strategies to cross-functional teams and external stakeholders.
• Ability to work hours necessary to support development and/or product transfer activities

Work Environment and Physical Demands

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

COVID Safety

In our commitment to the safety of our employees and customers, a COVID vaccination is required.

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