Senior Scientist, Process Development - Upstream

Job Description

Job Description

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 Team

The Upstream Process Development Department is responsible for designing and optimizing the production processes of Adeno-Associated Virus (AAV) vectors, which are essential components in gene therapy treatments.

This 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

The Senior Scientist, Process Development Upstream you will play a critical role in driving the development and optimization of AAV manufacturing processes.

This individual will provide technical leadership, mentorship, and strategic insights to the team, contributing to the organization's long-term success and to the advancement of AAV manufacturing processes.

What You'll Do

• Lead and oversee complex experiments for AAV upstream process development, utilizing single-use bioreactors and advanced techniques.
• Provide technical expertise in bioreactor operation, cell culture, and transfection, acting as the Subject Matter Expert (SME).
• Drive process optimization initiatives to enhance AAV yields, quality, and scalability, contributing to project leadership.
• Conduct independent research and lead projects, compiling and contributing experimental data for publications or reports.
• Independently present results and prepare publications or reports, demonstrating strong communication skills.
• Manage and mentor junior team members, reviewing expertimental data and providing guidance and direction.
• Perform individual performance reviews, providing coaching / feedback to ensure employee development.
• Generates protocols / templates that can be utilized by junior team members.
• Develop and revise standard operating procedures (SOPs) and batch records to ensure process consistency.
• Contribute to the development and implementation of innovative process development strategies.
• Oversee day-to-day laboratory activities, including equipment maintenance, supplies management, and cleanliness.
• Support internal process transfer activities from Process Development to GMP.
• Demonstrate a breadth of scientific expertise (knowledge and technique) in laboratory functions that are pertinent to company goals.
• Collaborate cross-functionally with research and manufacturing teams to ensure seamless technology transfer and process implementation.
• Develop and execute process validation strategies and support regulatory filings.
• 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.

What You'll Bring

• Bachelor's Degree in Chemical Engineering, Biomedical Engineering, Biology, or related discipline (or equivalent experience).
• Working knowledge of cell culture techniques utilizing mammalian, insect, or microbial cells.
• Technical expertise in upstream process development and scale up principles.
• Proven ability to operate and troubleshoot bioreactors.
• Experience planning, conducting and reviewing experimental data with minimal oversight.
• Experience analyzing data sets and utilizing the corresponding data to influence decision making.
• Prior experience working with internal / external stakeholders and presenting data to drive decisions.
• Experience directly managing junior team members.

Preferred Skills

• Master's Degree or PhD in Chemical Engineering, Biomedical Engineering, Biology, or related discipline (or equivalent experience).
• Experience working with viral vectors (AAV, Lentivirus, etc.).

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.

H ARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

O PEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

P URPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

E NGAGED - 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 Un FORGE ttable.

• 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
2 days ago