What are the responsibilities and job description for the Quality Control, Analyst I position at Forge Biologics?
About Forge
Forge Biologics, 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 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 currently seeking a Quality Control (QC) Analyst I, Analytical Testing, to join the Forge Biologics team. This role will perform characterization and release testing QC for AAV vectors, plasmids, and cell banks, while maintaining meticulous records and ensuring the accuracy of data for all products. This position is responsible for routine test method execution, assisting in method qualification and validation, instrumentation troubleshooting, and data analysis. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector. The Analyst I role offers an excellent opportunity to gain hands-on experience in the field of gene therapy.
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 Biologics, 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 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 currently seeking a Quality Control (QC) Analyst I, Analytical Testing, to join the Forge Biologics team. This role will perform characterization and release testing QC for AAV vectors, plasmids, and cell banks, while maintaining meticulous records and ensuring the accuracy of data for all products. This position is responsible for routine test method execution, assisting in method qualification and validation, instrumentation troubleshooting, and data analysis. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector. The Analyst I role offers an excellent opportunity to gain hands-on experience in the field of gene therapy.
What You'll Do
- Perform in-process, release, and stability testing for our most advanced AAV-based (viral vector) therapeutic candidates, plasmids, and coli master cell banks manufactured internally.
- Lead the execution of complex analytical tests and assays, including qPCR, ddPCR, ELISA, cell-based assays, and capillary electrophoresis, to assess the quality, potency, and safety of AAV vector products.
- Contribute to the design, optimization, and validation of novel analytical methods to enhance quality control processes.
- Utilize molecular biology techniques including DNA and RNA extraction, gel electrophoresis, and PCR to support product characterization.
- Maintain detailed records of experimental procedures, outcomes, and observations following Good Documentation Practices (GDP).
- Adhere to established Standard Operating Procedures (SOPs), cGMP guidelines, and regulatory requirements during all tasks.
- Collaborate closely with cross functional team to address quality related concerns and facilitate timely product release.
- Participate in equipment maintenance, calibration, and qualification activities to ensure reliable test results.
- Assist in sample coordination for contract testing, ensuring proper paperwork is completed and shipping procedures are followed.
- Support the QC management team for activities related to characterization, release, and stability testing, compliance with GMP, and identifying and implementing corrective and preventive actions.
- Bachelor's degree in biology, biochemistry, molecular biology, or a related field with 0-3 years of related experience
- Experience with a wide range of molecular biology, cell biology techniques and analytical methods (e.g., qPCR, ddPCR, cell-based assays, ELISA)
- Experience and knowledge in the pharmaceutical and/or biotech industry in testing within a GxP environment is preferred
- Experience with assay execution, validation, and optimization is preferred.
- Skills and the ability to generate actionable insights from experimental results.
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 paid time off plan (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
