About Forge
Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping 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 Role
As a member of the Analytical Development group, this position will help drive the development of cell based AAV gene therapy potency assays. The position requires a strong background in cell culture and experience in cell-based assay method development. The individual needs demonstrable experience in managing cell lines, including wild type and engineered. You will be responsible for the design and optimization of biological / molecular assays including, but not limited to, virus transduction, qPCR/ddPCR, enzyme activity measurement, immunoassays, and flow cytometry for evaluation of final and in-process gene therapy vectors. This position is also responsible for clear and timely documentation of assay results and communicating data to internal and external stakeholders, as well as reviewing the data of junior team members. This role supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs).
What You’ll Do
- Design and execute cell bioanalytical assays to support manufacturing, purification and clinical comparability of AAV gene therapy products
- Evaluate cell culture models for use in potency assays for multiple new gene therapy programs.
- Perform cell based assays to assess the in vitro potency of novel AAV gene therapy drug products
- Ability to perform or learn other analytical assays such as RT-qPCR, ddPCR, ELISA, Flow Cytometry, and Western Blot
- Work seamlessly with cross functional stakeholders including Process Development, Product Development, and Quality Control to help advance the AAV vector production portfolios
- Create and maintain clear and concise lab records and documentation
- Author study plans, development reports, and method protocols in accordance with ICH and USP guidance
- Maintain clean and fully functional laboratory and adhere to all laboratory standards as defined in SOPs
- Ensure that scientific and technical challenges are resolved in a timely manner
- Contribute to a safe, efficient, and effective environment with personal accountability
What You’ll Bring
- PhD in Molecular Biology, Biotechnology, Biochemistry, Immunology, Virology, or a related field with 0-2+ of relevant experience, or MS with 6+ years of related experience in assay development
- Experience with aseptic techniques in mammalian cell culture systems and performing bioassays
- Experience in gene therapy and/or vaccine testing is preferred
- Prior experience performing viral genome titer, infectivity, potency, host cell protein, and host cell DNA assays is desirable
- Experience with ddPCR, ELISA, SDS-PAGE and Western Blot is desirable
- Excellent written and verbal communication skills
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
- Ability to work with a high attention to detail with minimal supervision
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects at various stages of development
- Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders
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
