Summary: The Downstream Manufacturing Technician II will work directly with a range of purification technologies and equipment including centrifugation, sucrose gradient separation, filtration, chromatographic separation (i.e. column chromatography) and viral inactivation following aseptic technique and GMP procedures.
- Technician II will be responsible for:
- Experience with GE AKTA systems.
- Continuous Flow Centrifugation.
- Filtration technologies including Tangential Flow Filtration, Depth Filtration and Clarification.
- Buffer Preparation.
- 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.
- Participate with senior staff in implementing project safety and quality assurance programs.
- Document and maintain activity records according to cGMP regulations.
- Perform daily cleaning and sanitization of the laboratory and manufacturing areas.
- Assist in training less experienced Manufacturing Technicians.
- 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, and 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 cleanroom environment with full clean room gowning and good aseptic technique.
- Must have good planning and time management skills and be willing and able to interface with colleagues in many different 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.
- 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 occasionally.
- 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
- Biotechnology Certificate