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
We are seeking a detail-oriented and highly motivated individual to join our Fill/Finish Manufacturing team. As a Senior Technician, GMP Manufacturing – Fill/Finish you will play a crucial role in the aseptic filling and finishing operations of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. This position presents an exciting opportunity to contribute to the manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.
What You’ll Do
- Execute aseptic filling and finishing operations according to Standard Operating Procedures (SOPs) and batch records, ensuring completion and compliance with cGMP guidelines and quality standards.
- Demonstrate proficiency and competency by ensuring all tasks are performed in a manner consistent with cGMP SOPs and safety standards.
- Prepare and operate filling equipment, such as semi-automated and automated fillers, stoppering machines, cappers, and labeling machines, following established procedures, and ensuring proper setup, calibration, and maintenance.
- Perform line clearances, sanitization, and sterilization activities for the filling equipment and manufacturing areas to maintain aseptic conditions.
- Assemble and disassemble equipment, such as filling heads, tubing, filters, and fittings, for cleaning and sterilization purposes, adhering to proper cleaning procedures.
- Monitor critical process parameters during filling and finishing operations, including fill volumes, stopper/cap placement, torque, and label alignment, and report any deviations or abnormalities to management
- Conduct in-process testing and quality control checks, such as visual inspections, particle count, and container closure integrity tests, to ensure product quality and compliance with specifications.
- Document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
- Drive ownership of deviations/discrepancies in collaboration with cross-functional teams, including Quality Assurance (QA), Quality Control (QC), Quality Validation (QE), and Facilities & Engineering (F&E) to investigate and resolve deviations, non-conformances, and quality incidents related to filling and finishing processes.
- Manage and assess Change Controls and CAPAs, contributing to impact assessments to support process improvements that enhance efficiency, productivity, and regulatory compliance within the Fill/Finish manufacturing area.
- Demonstrate good aseptic techniques and serve as a trainer and mentor to junior technicians.
- Qualify for ISO-6 cleanroom gowning protocol and maintain annual certification to ensure compliance with GMP standards.
- 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.
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).
- 4+ years of experience in aseptic techniques and troubleshooting fill/finish equipment.
- Able to perform multi-hour processing events within controlled cleanroom environment while maintaining ISO-6 cleanroom gowning protocol.
- Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
- Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
- 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.
- Cleanroom ISO-6 gowning experience is preferred.
- BioSafety Cabinet (BSC) aseptic operator qualification and first air processing experience is preferred.
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
