Associate Scientist I, Gmp Manufacturing - Downstream

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 GMP Manufacturing department is responsible for the manufacturing of AAV Gene Therapy products in accordance with the highest standards of Good Manufacturing Practices (GMPs). This department ensures that the products produced are of the highest quality and meet all applicable regulatory requirements. This team works together to ensure the production of safe and effective Gene Therapy products.
About The Role
The Associate Scientist I, GMP Manufacturing - Downstream is responsible for the operation, maintenance, and troubleshooting of the downstream production systems. The Associate Scientist I will be responsible for following SOPs and GMP guidelines to produce AAV Gene Therapies to the highest quality standards. The technician will also be responsible for monitoring and recording critical process parameters, performing equipment cleaning, and troubleshooting basic issues.
What You’ll Do

• Monitoring, operating, and troubleshooting downstream production systems and processes.
• Plans work to meet production and schedule requirements from clients (internal and external).
• Prepares data associated with manufacturing processes and transfer activities to clients.
• Performs manufacturing activities and sampling that incorporates application of GMP principles and methodologies.
• Ensuring compliance with SOPs, cGMP, and safety guidelines.
• Additional responsibilities not listed may be assigned as needed by management.
• Supports internal process transfer activities and may serve as Subject Matter Expert (SME) to troubleshoot processes.
• Assisting in the development of SOPs and work instructions for downstream production processes.
• Supports thorough investigations to determine root cause of OOS investigations the implementation of appropriate corrective and preventative actions in a timely manner.

What You’ll Bring

• Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience)
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to work in confined spaces and near operating equipment.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room gowning attire as needed.
• Ability to work hours necessary to support production and/or product transfer activities.

Preferred Skills

• Experience with chromatography systems
• Working knowledge of cGMP and ISO guidelines

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.

• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Annual bonus for all full-time employees
• Unlimited PTO (plus 14 paid company holidays)
• Fully-stocked kitchen with free food/drinks
• 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
• 401(K) company match
• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches
• Equity-incentive plan
• Employee Assistance Program