Summary: The Downstream Manufacturing Technician I will work directly with viral purification (either whole particle or split particle), continuous flow centrifuge operation, and sucrose gradient separation, techniques for filtration and chromatographic separation (i.e. column chromatography and HPLC) and viral inactivation.
- Technician I will be responsible for:
- Systems setup and turnaround of GE AKTA systems.
- Continuous Flow Centrifugation.
- Tangential Flow Filtration.
- Depth Filtration and Clarification.
- Buffer Preparation and filtration.
- Operate general production equipment such as Autoclaves, Glass washers, Incubators, Scales, pH/conductivity meters, etc.
- Assist in writing standard operating procedures and batch production records in accordance with SOPs.
- Document and maintain activity records according to cGMP regulations.
- Maintain the confidentiality of proprietary company information.
- Perform daily cleaning and sanitization of the laboratory.
- Maintain effective working relationships with others.
- Perform all other duties as assigned.
Required Skills & Abilities:
- Good oral and written communication skills, interpersonal and organizational skills.
- Strong 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 including opportunities for overtime.
- Good math and computer skills.
- Must possess good 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 of hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing environment.
- Lift up to 25 pounds frequently and up to 50 pounds occasionally.
- Attendance is mandatory.
- Associates degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field; OR
- High School Diploma/GED with 1 year of work experience.
- Experience in a GMP environment