GMP Technician I, Upstream

About The Role:

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:

• Associate’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.
• 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.
• Work Environment and Physical Demands
• This position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.
• 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.