Summary: The Upstream Manufacturing Technician II will work directly with cell culture and viral propagation techniques, buffer and equipment preparations, cell culture and bioreactor operation, bacterial and fermentation operations, and aseptic technique following GMP procedures.
- Prepare medium and equipment, monitor cultures, take samples, turn-around of fermenters and bioreactors, sterilization and inoculation.
- Plate counting, microscopic examination.
- Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
- Participate in writing standard operating procedures and batch production records.
- Experience with cultivation and/or pilot scale cell culture vessels.
- Participate with senior staff in implementing project safety and quality assurance programs.
- Maintain the confidentiality of proprietary company information.
- Document and maintain activity records according to cGMP regulations.
- Perform daily cleaning and sanitization of the laboratory.
- Maintain an effective working relationship with others.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Excellent oral and written communication skills, interpersonal and organizational skills.
- Excellent proficiency with Microsoft Office applications.
- Good self-discipline and attention to detail.
- Must have flexible work hours – must be willing to work outside of normal scheduled hours as necessary. Must be able to work alternative shift hours and weekends as required.
- Good math and computer skills.
- Experience working in a clean room environment.
- Must possess excellent planning and time-management skills, and be willing and able to interface with colleagues in various roles and functions, throughout the manufacturing facilities.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
- Attendance is mandatory.
- Bachelor’s degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 2 years of relevant experience: OR
- Associate’s degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 3 years of relevant experience; OR
- High School/GED with 5 years relevant experience.
- Experience in GMP environment