Manufacturing Associate, Downstream

Executes routine 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.

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.

This may include parts cleaning and weighing and dispense.

Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.

Moderate - strong focus on execution of routine tasks with moderate technical complexity. Performs highly procedural tasks.

Basic interactions: Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control

Basic knowledge of fundamental manufacturing concepts is preferred. Does not require extensive technical knowledge of manufacturing operations.

1 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.