Job Summary:
Responsible for the manufacture of GMP oligonucleotides; the continuous improvement of these existing oligo processes; and the development/transfer of new oligo processes.
Provides oligo process support to Operations group through instrument/oligo process troubleshooting and completion of NCR investigations. Responsible for research, development and production manufacturing activities associated with oligos.
Essential Duties and Responsibilities:
· The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
· Independently produces notebook, dev, pilot and production materials per written directions.
· Analyzes in-process and final oligos using state of the art analytical techniques.
· Troubleshoots simple manufacturing process problems.
· Analyzes process data.
· Creates documents and assists with assembly of change control packages.
· Maintains labs under cGMP conditions.
· Completes ERP and cycle count transactions.
· Keeps accurate records and documentation.
· Stocks and maintains lab supplies.
· Physical Demands (Please check all applicable boxes)
· The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
· Sit; use hands to finger, handle or feel objects, tools, or controls.
· Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
· Lifting/moving and carrying products weighing up to 40 pounds.
· Exposure to moving mechanical parts, vibration and/or moderate noise levels.
· Exposure to hazardous chemicals or other materials.
· Safety Shoes with Impact and Compression Protection Must be worn.
· Exposure to blood.