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Senior Manufacturing Associate
1 month ago
Senior Manufacturing Associate-Downstream
This is a Temp to Perm situation.
Swing shift: 2pm-12am, W, Th, F, Sat 10 hour days.
On-site in Fremont, CA.
Executes and coordinates unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.
Independently executes complex unit operations including but not limited to chromatography operations, tangential flow filtration, various filtration methods, and process monitoring. May contribute to equipment and process troubleshooting, as needed. Implements continuous improvement projects of low complexity in the production areas.
Executes independently with adequate training fundamental operations:
-CIP/SIP of tanks, transfer lines, and process equipment.
-Buffer preparation and transfer into tanks and disposables.
-Performs In process testing for samples e.g. spectrophotometry, pH, conductivity, and maintenance of analytical equipment.
May contribute to equipment and process troubleshooting, as needed. Implements continuous improvement projects of low complexity in the production areas.
Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
Documents work according to cGMP and cGDP.
Adheres to established regulations and follows cGMP established by site.
Reports abnormalities and deviations in a timely and accurate manner.
Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
Maintains production areas according to predefined standards.
Basic interactions:
Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control
Strong working knowledge of fundamental manufacturing concepts is required. Moderate technical knowledge of biologics operations is preferred.
2 or more years of experience in cGMP regulated industry.
-Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first time mindset.
-Strong written and verbal communication skills.
-Ability to work with computer-based systems and ideally experience with process control systems (e.g. Delta V) and manufacturing execution systems (MES).
-Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
-Ability to work as part of a high performing team and collaborate effectively with staff.
