What are the responsibilities and job description for the Technician II, GMP Manufacturing - Upstream position at Forge Biologics?
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 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
We’re seeking an experienced and detail-oriented professional to join our Upstream Manufacturing team as a Technician II, GMP Manufacturing. In this role, you’ll be hands-on in the production and cultivation of AAV-based gene therapy products, ensuring compliance with cGMP regulations every step of the way. This is an exciting opportunity to utilize your expertise in upstream bioprocessing and contribute to the manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.
What You’ll Do
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.
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 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
We’re seeking an experienced and detail-oriented professional to join our Upstream Manufacturing team as a Technician II, GMP Manufacturing. In this role, you’ll be hands-on in the production and cultivation of AAV-based gene therapy products, ensuring compliance with cGMP regulations every step of the way. This is an exciting opportunity to utilize your expertise in upstream bioprocessing and contribute to the manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.
What You’ll Do
- Execute and oversee upstream manufacturing operations, including cell culture expansion, transfection, and harvest steps, according to Standard Operating Procedures (SOPs) and batch records.
- Prepare and operate bioreactors, centrifuges; filtration systems, and other equipment required for upstream processing, ensuring proper calibration, maintenance, and troubleshooting when needed.
- Perform complex media and buffer preparation, as well as the aseptic transfer of materials, adhering to cGMP guidelines.
- Monitor process parameters during manufacturing operations, analyze data, and proactively identify and report deviations.
- Conduct sampling and in-process testing, such as cell counts, viability, and metabolite analysis, and other analytical techniques, to ensure product quality.
- Accurately document all manufacturing activities, data, and results in accordance with cGMP regulations and company policies.
- Partner with Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents.
- Support process improvement initiatives, including evaluating new technologies, equipment, and methods to enhance manufacturing efficiency, productivity, and compliance.
- Mentor and train junior technicians, providing guidance on procedures and best practices.
- Follow safety protocols and maintain a clean, compliant work environment.
- Stay informed on industry trends, regulatory requirements and share knowledge with team.
- Bachelor’s Degree in Biology, Biochemistry, Biomedical Engineering or related field (or equivalent experience).
- Experience working in a GxP or regulated environment.
- Hands-on experience with cell culture techniques, bioreactors, centrifuges, filtration systems, and other upstream processing equipment.
- Skilled in aseptic techniques, media and buffer preparation, and upstream analytical methods.
- Detail-oriented with strong documentation and data recording skills.
- Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
- Strong teamwork and communication skills to collaborate effectively across departments.
- Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
- Experience and ability to mentor and train junior team members.
- Ability to work flexible hours, including evenings, weekends, and holidays to support manufacturing production schedules.
- Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.
- Prior cGMP manufacturing experience.
- Upstream bioprocessing or biologics manufacturing experience.
- Familiarity with viral vector-based gene therapy processes and quality requirements.
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
- Competitive 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
- Onsite gym
- Wellness benefits (financial planning services, mental health counseling, employer paid disability)
- Professional & Personal development resources
