The Biomanufacturing Technician I is responsible for performing various manufacturing activities related to the start-up and GMP production of a number of novel cellular products including compliance with regulatory agencies and associated guidelines. Must be able to work night weekends and holidays. Must be able to meet physical requirements established in this job description.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Obtain and maintain qualifications necessary for the performance of aseptic activities.
Responsible for the production formulation and banking of cellular products (including GMP GDP and aseptic processing).
Write under supervision GMP required documents including standard operating procedures product specifications equipment specifications and batch production records.
Provide support in validation efforts related to the manufacturing process.
Participate in all aspects of manufacturing activities including raw material support cell culture and continuous improvement.
Consistently practice appropriate clean room behaviors and upkeep of clean room
areas.
Perform all other related duties as assigned.
QUALIFICATIONS:
Associate degree in a scientific field strongly preferred.
High school diploma or equivalent required.
Zero to 1 year of applicable experience in biotech or cell therapy.
May consider less education and professional experience upon successful completion of Charles Rivers internship program.
Must be able to work in a clean room environment that potentially includes hazardous materials and medical equipment (including blood tissues and needles)
Must have ability to perform algebraic math.
Must be detail oriented and have excellent organizational skills.
Must possess effective written and oral communication skills.
Must display a high degree of professionalism and confidentiality.