Assistant I, Manufacturing Operations
- Expired: over a month ago. Applications are no longer accepted.
The Assistant I, Manufacturing is a regular employee 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 Client's policies, 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
- Glasswasher and autoclave
- Media and buffer preparation
- Filtration systems
- Inoculation of mammalian or cytokines cells
- Fermentation and harvest
- Chromatography columns
- Aseptic filling
- Responsible for in-process testing, such as: pH, Conductivity, Spectrophotometer, Osmometer, Cell count, YSI, Blood Gas Analyzer (BGA), etc.
- Will verify all raw materials and commodities.
- Responsible of equipment's assembly, cleaning, sterilization and operation.
- Prepares media and buffer solutions.
- Will electronically record all the process steps.
- 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
- Associate degree in Science, major in Biology, Chemistry or Biotechnology with at least two years of experience in biotechnology field OR
- BS degree in a Biotechnology, Biology or Chemistry with less than two years of experience in biotechnology field OR
- Zero to 2 years of experience in biotechnology field.
- Aseptic techniques and clean room manufacturing experience is preferred.
- 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.
- 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:
- Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.
- 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, Aseptic Sampling, Filter Integrity Testing, Fermentation Process, Inoculation Process, Chromatography Columns, Osmometer, Weigh Scales, 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.
Unicon Pharma Inc.
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