The Manufacturing Associate I, is a regular employee in a full-time non-exempt position, you will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning.procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.
Essential Duties & Responsibilities
Will be assigned to the daily operations, working with:
Weighing and dispensing of material
Filtration systems
Inoculation of mammalian or cytokines cells
Fermentation and harvest
Chromatography columns and TFF operations
Responsible for in-process testing, such as: pH, Conductivity, Spectrophotometer, Osmometer, Cell count, etc.
Prepares media and buffer solutions.
Completes Batch Records and other cGMP documentation accurately and in a timely manner.
Remove and dispose soiled materials from the manufacturing area.
Will assure that the manufacturing areas are maintained within the required conditions for clean room manufacturing.
Will report all nonconformance or events that arise during the shift to the Supervisor.
Assists in the transfer of technology from Process Development to cGMP Manufacturing.
Complies with all safety, cGMP and Company policies, practices and procedures.
Performs other functions as required or assigned
Complies with all company policies and standards
Position Requirements and Qualifications
Education:
Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred
Or an equivalent of 1 - 2 years of biologics industry experience required
Special Skills
Language:
Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English.
Excellent interpersonal skills.
Reasoning Skills:
The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes
Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.
Computer and/or Technical Skills:
Operation and understanding of word processing, spreadsheets, and data management
Knowledge of GMP and safety requirements.
Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Fermentation Process, Inoculation Process, Chromatography Columns, TFF step etc.
Work Environment & Physical Demands:
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Must be able to work on rotating shifts
1st: 6:00am - 2:30pm (2 weeks)
2nd: 2:00pm - 10:30pm (2weeks)
3rd: 10:00pm - 6:30am (2 weeks)
Employment Type: Contractor
Salary: $ 35.00 Per Hour
