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Form of workJob Description
Title: Manufacturing Associate Level I – Drug Product
Location: Chicago, IL
Duration and hire type: Contract to Hire
Overview: Sterling Engineering / Staffing is currently looking for a Manufacturing Associate Level I – Drug Product for one of our clients in the Chicago, IL area. Sterling has a rich history of delivering top talent to our clients. We are a nationwide Staffing Firm with over 100 clients and works primarily with Fortune 1000 corporations.
Job Description:
The Manufacturing Associate I 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. Must comply with policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.
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
Education/Training:
- Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred
- Or an equivalent of 1 – 2 years of biologics industry experience required
Qualifications and Experience:
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. Some travel may be involved
- Supervisory Responsibility, if any: No
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
