- Operation of chromatographic systems (Single Use GE AKTA).
- Operation of filtration systems including Tangential Flow Filtration, Depth Filtration and Clarification.
- Prepare and formulate buffers in accordance to procedures.
- Assist in writing and reviewing standard operating procedures and batch production records.
- Initiating deviations as needed, reporting and assisting in solving problems and issues.
- 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 assist in training junior team members.
- Assist in the training and provide technical coaching to junior staff members.
- Perform daily cleaning and sanitization of the manufacturing areas as needed.
- Maintain an effective working relationship with others.
- Perform all other duties as assigned.
NCTM/Building 200 Essential Functions:
- Column chromatography
- Fermentation and non-mAb applications
- Continuous flow centrifugation
- Sucrose gradient separation
- Operate and use general production equipment such as Autoclaves, Glass Washers, Incubators
Building 100 Essential Functions:
- Assist in mammalian cell culture processes, including: shake flask inoculations, single use bioreactor operations, and cell recovery.
- Producing requirements by assisting in operating and monitoring equipment, observing varying conditions, adjusting equipment controls, calculating concentrations, dilutions, and yields.
- Assist in the operation of general production equipment such as Analytical Scales, pH/conductivity meters, Autoclaves, Incubators, etc.
Required Skills & Abilities:
- Good oral and written communication skills, interpersonal and organizational skills.
- Proficient with Microsoft Office applications.
- Good leadership skills.
- Ability to assist in training 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.
- 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 of relevant experience.
- Biotechnology certificate preferred.
- Cross training with Upstream processes or other identified functional areas.
- One (1) year GMP experience