GMP Technician I, Upstream

About The Role

We are seeking a detail-oriented and highly motivated individual to join our GMP Manufacturing, Upstream team. As a Technician I, GMP Manufacturing - Upstream you will play a critical role in the production and cultivation of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. This position offers an exciting opportunity to contribute to the development and manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

Responsibilities

• Execute upstream manufacturing operations, including but not limited to 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 they are properly calibrated and maintained.
• Perform media and buffer preparation, as well as the aseptic transfer of materials, adhering to cGMP guidelines and maintaining a clean and organized work area.
• Monitor critical process parameters during manufacturing operations and report any deviations or abnormalities to the supervisor in a timely manner.
• Conduct sampling and in-process testing, such as cell counts, viability, and metabolite analysis, to ensure optimal culture conditions and product quality.
• Document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
• Collaborate with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents related to upstream manufacturing processes.
• Participate in process improvement initiatives and support the implementation of new technologies, equipment, and methods to enhance manufacturing efficiency and productivity.
• 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.

Qualifications

• Ace’s or Bachelor’s degree in a scientific field, or relevant industry certifications; or high school diploma with +2 years of related experience.
• Previous experience working in a regulated manufacturing or laboratory environment.
• 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.
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
• Strong problem-solving skills and ability to identify and escalate issues as needed.
• 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 production schedules.
• Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

Preferred Skills

• Prior experience working in a cGMP manufacturing environment.
• Upstream bioprocessing or biologics manufacturing experience.
• Familiarity with cell culture techniques, bioreactors, centrifuges, and filtration systems.
• Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.