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Sr. Technician, GMP Manufacturing - Downstream

Forge Biologics

Forge Biologics

Columbus, OH, USA
Posted on Thursday, June 27, 2024

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 an experienced and highly skilled individual to join our Downstream Manufacturing team. As a Senior Technician, GMP Manufacturing - Downstream you will play a pivotal role in the purification and processing of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. Your expertise in downstream bioprocessing and strong leadership abilities will contribute to the success of our manufacturing operations and the delivery of cutting-edge gene therapies that have the potential to transform the lives of patients.

What You’ll Do

  • Lead and execute downstream manufacturing operations, including but not limited to chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, according to Standard Operating Procedures (SOPs) and batch records.
  • Independently prepare, operate, and troubleshoot advanced downstream equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring optimal performance and compliance.
  • Monitor critical process parameters during manufacturing operation, analyze data, and proactively identify and address deviations or abnormalities, ensuring timely reporting and resolution.
  • Perform in-process testing and quality control checks, such as pH, conductivity, pressure measurements, and other analytical techniques to ensure product quality and compliance with specifications.
  • Lead and document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
  • Collaborate closely with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents, ensuring compliance with regulations and meeting production timelines.
  • Drive process improvements by evaluating new technologies, equipment, and methods, and leading the implementation of strategies to enhance manufacturing efficiency, productivity, and compliance.
  • Mentor and train junior team members, providing guidance on process execution, troubleshooting, and adherence to cGMP guidelines.
  • Ensure the highest standards of safety procedures and environmental health and safety guidelines are followed, maintaining a safe working environment.
  • Stay updated with the latest advancements in gene therapy downstream manufacturing processes, regulatory requirements, and industry trends, and actively contribute to the continuous improvement of manufacturing practices.

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).
  • Prior experience working in a GxP or regulated environment.
  • Downstream processing or biologics manufacturing experience.
  • Extensive expertise and hands-on experience with downstream processing techniques and equipment, such as chromatography systems, filtration systems, centrifuges, and TFF systems.
  • Proficiency in conducting in-process testing and quality control checks to ensure product quality and compliance..
  • Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
  • Excellent attention to detail and ability to accurately document and record experimental data and manufacturing activities.
  • Strong organizational skills and the ability to manage multiple tasks, prioritize effectively, and meet project timelines in a fast-paced environment.
  • Exceptional interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders.
  • Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
  • Demonstrated leadership abilities, including experience in mentoring and training junior team member.
  • Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules. Preferred Qualifications:.
  • Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

Preferred Skills

  • Familiarity with purification techniques and equipment commonly used in downstream bioprocessing, such as chromatography systems, filtration systems, and TFF systems.
  • Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

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