Technician I, GMP Manufacturing - Upstream - job 1 of 2

As a Technician I, GMP Manufacturing – Upstream at Forge, your responsibilities include executing upstream operations such as cell culture expansion, transfection, and harvest steps. You'll also prepare bioreactors and other essential equipment, ensuring all tasks comply with cGMP regulations. Monitoring critical process parameters, conducting in-process testing, and collaborating with teams for quality assurance are key duties that contribute to the production of high-quality gene therapy products.

To apply for the Technician I, GMP Manufacturing – Upstream role at Forge, you should have an Associate's or Bachelor's degree in a scientific field, relevant industry certifications, or a high school diploma with at least two years of related experience. Previous experience in regulated manufacturing environments is preferred, and essential skills include excellent organizational abilities, strong interpersonal communication, and a commitment to following SOPs and safety protocols.

At Forge, a Technician I works in both laboratory and typical office environments. This position requires adherence to strict safety protocols, and personal protective equipment is mandatory in laboratory settings. You will engage in tasks that may involve extended periods of standing, cleanroom environments, and working with precision to manage manufacturing processes effectively.

Forge is committed to the growth and development of its employees, including Technician I team members. We offer professional and personal development resources, providing opportunities for training on the latest industry trends and advancements in gene therapy manufacturing processes. Additionally, Forge actively encourages participation in process improvement initiatives and supporting the adoption of new technologies.

The team culture at Forge is characterized by our core values that foster a supportive and engaged environment. As a Technician I, you'll find yourself among diverse, driven colleagues who are passionate about their work. We prioritize collaboration, creativity, and a patient-first approach, ensuring that everyone feels valued and empowered to contribute to our mission of producing life-changing therapies.

To ensure compliance with cGMP standards, it’s crucial to follow SOPs rigorously, maintain meticulous documentation, and adhere to safety protocols. You should also be vigilant about monitoring the manufacturing process and quickly reporting any deviations or abnormalities to your supervisor. Continuous training and familiarization with regulatory guidelines are essential for staying compliant.

When asked about experience with bioreactors, explain your background in operating and maintaining these systems, including the specific types you have worked with. Highlight any relevant techniques you’re familiar with, such as feeding strategies and monitoring critical parameters like pH and oxygen levels, and how these experiences have prepared you for the role at Forge.

Key factors in cell culture expansion include selecting the right cell line, optimizing growth conditions like temperature and media composition, and monitoring for contamination. Discuss your understanding of aseptic techniques and how you’ve previously applied them in lab settings to ensure successful cultures.

When troubleshooting manufacturing processes, I prioritize identifying the root cause by closely monitoring process parameters, conducting tests, and collaborating with team members. It’s essential to maintain detailed records to analyze trends and employ critical thinking to propose effective solutions while ensuring minimal disruption to production.

In your response, detail your experience preparing various media and buffers, including the specific types used for upstream processes. Mention your familiarity with measuring and mixing components accurately, maintaining sterility, and following SOPs to produce optimal conditions for cell growth and product quality.

Working under pressure effectively involves prioritizing tasks, staying organized, and maintaining clear communication with team members. Share examples of how you've successfully managed multiple responsibilities in high-stress situations, and emphasize the importance of remaining focused on safety and compliance even during peak production times.

Collaboration is vital in GMP manufacturing as it ensures alignment between departments such as Quality Assurance and Quality Control. Discuss how you’ve previously collaborated on projects, shared insights, and supported team goals to resolve issues and improve processes, highlighting the importance of teamwork in achieving high product standards.

Explain a specific instance when you noticed a deviation, detailing your observation process, how you reported it, and the corrective actions taken. Highlight your ability to communicate effectively with your team and supervisors while ensuring compliance with cGMP standards and contributing to continuous improvement.

When answering this question, share your passion for science and how it drives your interest in gene therapy. Discuss the impact of these therapies on patients' lives, and convey your commitment to being part of the innovative developments in the industry that align with a patient-first approach, just as Forge embodies.

Staying updated with current biomanufacturing trends is crucial, and I do this by following relevant industry publications, attending webinars, and participating in professional organizations. Discuss specific resources you engage with and how you apply this knowledge in your work, ensuring you remain aligned with advancements that can benefit Forge and its mission.