Assistant II, Drug Product manufacturing
- Expired: over a month ago. Applications are no longer accepted.
The Assistant II, Drug Product Manufacturing is a regular employee will be responsible for the aseptic manufacturing of Drug Product, visual inspection and Secondary Packaging for clinical and commercial products for 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
- Aseptic filling of glass vial and pre-fillable syringes.
- Visual inspection of glass vial and prefilled syringes
- Responsible for in-process testing, such as: pH, Conductivity etc.
- Will verify all raw materials and commodities.
- Responsible of equipment's assembly, cleaning, sterilization and operation.
- Completes Batch Records and other cGMP documentation accurately and in a timely manner.
- Removes 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
- Writes, reviews and makes recommendations for change to cGMP documentation such as SOPs and Batch Records.
- Assists with new employees' trainings.
- Supports coordination of activities as necessary
- Performs other functions as required or assigned
- Complies with all company policies and standards
Position Requirements and Qualifications
Education and experience:
- Associate degree in Science, major in Biology, Chemistry or Biotechnology with at least one year of experience in aseptic product manufacturing.
- BS degree in a Biotechnology, Biology or Chemistry with one to three years of experience in pharmaceutical / biotechnology field.
- MS degree in a Biotechnology, Biology or Chemistry with less than one year of experience in pharmaceutical / biotechnology field.
- Aseptic techniques and clean room manufacturing experience, 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.
Unicon Pharma Inc.
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