Summary: The Downstream Manufacturing Technician III will work directly with a range of purification technologies including continuous flow centrifugation, sucrose gradient separation, filtration technologies (TFF and depth), chromatographic separations (GE AKTA systems), and viral inactivation following aseptic technique in a cGMP environment.
- Operation of chromatographic systems (GE AKTA).
- Operation of large scale centrifugation equipment.
- Operation of filtration systems including Tangential Flow Filtration, Depth Filtration and Clarification.
- Write and review standard operating procedures and batch production records.
- Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
- Maintain the confidentiality of proprietary company information.
- Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
- Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
- Perform daily cleaning and sanitization of the laboratory and manufacturing areas.
- 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.
- Proficient with Microsoft Office applications.
- Excellent leadership skills.
- Ability to train others to perform to cGMP standards.
- 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.
- Excellent 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.
- Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 1 year of relevant experience; OR
- Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 3 years of relevant experience; OR
- Associate’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 5 years of relevant experience; OR
- High School/GED with 7 years of relevant experience.
- Above experience must include one (1) year GXP experience.
- Biotechnology certificate preferred.
- Cross training with Downstream processes or other identified functional areas.