Job Description
Job Summary:
- The Biomanufacturing Technician I is responsible for performing various manufacturing activities related to the start-up and GMP production of a number of Client 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.
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.
Education and Experience:
- 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 client’s internship program.
Knowledge, Skills and Abilities:
- 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.