Production Chemist - Synthesis
San Diego Metro Area, CA
Responsible for the manufacture of oligonucleotides to be used in bulk clinical and commercial kit reagents.
Responsible for synthesis, purification and diafiltration of oligonucleotides, raw material prep and/or processing, and in-process testing.
Participate in transfer, support activities and continuous improvement on existing processes.
May be assigned to one or more functional Manufacturing areas.
1. Responsible for the staging of raw materials and synthesis and labeling of oligonucleotides
2. Maintains, measures and dispenses materials
3. Operates CIP and/or autoclave systems
4. Performing Enterprise Resource Planning (ERP) transactions
5. Performing regular cycle count activities to maintain inventory accuracy
6. Verify materials for manufacturing work orders
7. Maintains accurate and complete training records
8. General manufacturing area housekeeping including cleaning of labware, equipment, shelves, benches and sinks and removing trash
9. Maintain detailed and accurate device history records and log books using Good Documentation Practices
10. Understands and executes written procedures in accordance with Current Good Manufacturing Practices (cGMP)
11. Basic knowledge in the set-up and operation of Akta Oligopilot Synthesizers, Aktapilot HPLC and Dionex chromatography systems
12. Basic knowledge in the operation of analytical balances, pipettes, filter integrity testers, rotovap, water baths and spectrophotometers
13. Completes and forwards device history records for review in a timely manner
Prior experience with Good Documentation Practices (GDP) is a plus
Basic knowledge of Microbiology, Biology or (Bio)Chemistry
Basic knowledge of laboratory science, procedures, techniques, instruments & equipment
Basic knowledge of general laboratory safety and record keeping
Prior experience in a Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is a plus
Basic knowledge of ERP systems is a plus
Ability to follow oral and written instructions
Basic knowledge of Microsoft Office software
Good organizational skills
Attention to detail
Repetitive standing, walking, bending and lifting up to 25 lbs.
Strong mathematical skills required
The physical demands:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Visually inspect components and final kits for compliance and specifications.
Close vision (20 inches or less) will be utilized and some color identification will be required.
Frequently required to stand, sit, use hands/fingers to handle or feel, perform reaching, bending, stooping or kneeling motions, and talk or hear.
Operators may be required to walk for a considerable amount of time.
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10-25 pounds in weight, frequently or continuously.
May move objects and/or materials using carts or pallet jacks.
Typically requires a high school diploma or Associate s degree
2 to 4 years of related experience with high school diploma
0 to 2 years of related experience with an Associate s degree