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.