Position Summary
This employee will be responsible for the manufacturing of Drug Substance, 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 policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.
Essential Duties & Responsibilities
· Will be assigned to the daily operations, working with:
o Weighing and dispensing of material
o Operation of Glasswasher and autoclave
o Media and buffer preparation
o Drug Substance manufacturing
o Filtration systems
o Aseptic filling of glass vial and pre-fillable syringes.
o Visual inspection of glass vial and prefilled syringes
· Responsible to train and follow aseptic practices in ISO 6 area.
· Responsible to participate in media fill operations.
· Responsible for secondary packaging, material issuance and visual inspection.
· Responsible for in-process testing, such as: pH, Conductivity etc.
· Will verify all raw materials and commodities.
· 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.
· 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 employee training.
· Supports coordination of activities as necessary.
Position Requirements and Qualifications
Education:
· Undergraduate with relevant experience in GMP.
· 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 two years of experience in pharmaceutical / biotechnology field.
