Associate Scientist I, Plasmid Development & GMP Manufacturing

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

About The Role

We are seeking a detail-oriented and highly motivated individual to join our Plasmid Development & GMP Manufacturing team. As a Associate Scientist I, Plasmid Development & GMP Manufacturing (position title to be determined based upon experience) you will be responsible for the production and purification of plasmid DNA in compliance with current Good Manufacturing Practices (cGMP) regulations. This position offers an exciting opportunity to contribute to the advancement of cutting-edge therapies with the potential to transform the lives of patients.

What You'll Do

• Assist with overall maintenance of the production and testing facilities. This includes but may not be limited to performing quality systems checks, buffer preparation, autoclaving of media, packing of biohazard material, monitoring or sanitizing equipment, preparing facility for production campaigns, and periodic cleaning of incubators, centrifuges, FPLCs, biological safety cabinets (BSCs), and other equipment.
• Execute upstream manufacturing processes, including media preparation, cell culture maintenance, and fermentation operations, to achieve optimal plasmid DNA yields.
• Perform downstream purification operations, such as chromatography, filtration, and precipitation, to isolate and purify plasmid DNA from cell lysates.
• Provide support in the receipt and distribution of incoming raw materials for research, preclinical, and clinical manufacturing.
• Unpack reagents, maintain proper cold storage, and restock supplies in storerooms and laboratories.
• Assist in maintaining proper inventories or raw materials and consumables.
• Conduct in-process testing and sampling to ensure product quality and consistency throughout the manufacturing process.
• Participate in equipment maintenance, calibration, and cleaning activities across both upstream and downstream operations to ensure the integrity and reliability of manufacturing equipment.
• Maintain accurate documentation of all manufacturing activities, including batch records, logbooks, and electronic records, in accordance with cGMP requirements.
• Report any discrepancies from protocols/study procedures to management.
• Package and ship finished product to clients in accordance with procedures and regulations.
• Collaborate with cross-functional teams, including Quality Assurance, Quality Control, and Process Development, to troubleshoot issues and drive process improvements.
• Participate in process improvement initiatives and support the implementation of new technologies, equipment, and methods to enhance manufacturing efficiency and productivity
• Follow safety procedures and adhere to environmental health and safety guidelines to maintain a safe working environment.
• Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes.
• Additional responsibilities not listed may be assigned as needed by management.

What You'll Bring

• Bachelor's Degree in Microbiology, Biochemistry, Chemical Engineering or related life science field (or equivalent experience).
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
• Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders.
• Ability to adapt to changing priorities and work independently as well as part of a team.
• Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.

Preferred Skills

• Experience with cell culture techniques utilizing mammalian, bacterial, or insect cell lines.
• Experience with downstream purification techniques such as chromatography, filtration (depth filtration, tangential flow filtration), and precipitation.
• Experience working in a GxP environment or other regulated industry.

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.

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
• Flexible PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• 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