Biomanufacturing Technician

Day Shift: 6:00am – 6:30pm rotating shift

2nd Shift: 10:30am – 11:00pm rotating shift (training will be on first shift)

• (2 shifts on, 2 shifts off, 3 shifts on, 2 shifts off, 2 shifts on, 3 shifts off with the 3-days falling Friday – Sunday)
• Built in OT based off the 2-2-3 set up (i.e. 48 hr week + 36 hr week = 84 hours for two-week period)

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.

• Obtain and maintain qualifications necessary for the performance of aseptic activities.
• Consistently practice appropriate clean room behaviors and upkeep of clean room areas.
• Responsible for the production, formulation, and banking of cellular products (including GMP, GDP, and aseptic processing).
• Participate in all aspects of manufacturing activities including raw material support, cell culture, and continuous improvement.
• Promotes safety and conducts themselves in accordance with all safety guidelines at all times.
• Perform proper disinfection methods, such as emptying trash, wiping equipment, and mopping ceilings, walls, and floors.
• Responsible for the operation and maintenance of all cleaning equipment.
• Responsible for the preparation of cleaning/sanitation solutions and cleaning materials.
• Identifies and communicates any material or procedural discrepancies.
• Provide support in validation efforts related to the manufacturing process.
• Write, under supervision, GMP required documents including standard operating procedures, product specifications, equipment specifications and batch production records.
• Adheres to all regulatory and compliance requirements defined in current Good Manufacturing Practices (cGMPs).
• Follows and executes Standard Operating Procedures (SOPs).
• Accurately documents cleaning activities in logbooks according to Good Documentation Practices (GDPs)
• Perform all other related duties as assigned.

• Associate degree in a scientific field strongly preferred. Will consider recent graduates.
• 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 the company's 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.