Sr Manufacturing Associate, Upstream, ONSITE, Fremont CA

Executes and coordinates unit operations in Upstream 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.

Responsibilities

• Independently executes complex unit operations including, but not limited to, batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations.
• 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 bioreactors, tanks, and harvest equipment; media preparation and transfer into tanks and disposables; cell inoculation and transfer; daily analytics and maintenance of analytical equipment.
• May be required to support parts cleaning and weigh and dispense operations.
• 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 (5s).
• Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
• Contributes to Quality activities such as investigations and area walk-throughs.

Requirements

• High school degree plus minimum two (2) years’ work experience in GMP regulated industry.
• Associates/Bachelor’s degree from an accredited institution or biotechnology vocational training 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.
• Requires moderate to high technical knowledge of biologics manufacturing operations.
• Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs, and BGSs for cGMP, EHS, and Compliance policies.
• Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.

Schedule

Wed - Sat, 8:00pm - 6:30am PST

Pay

The base salary range for this position is $75,000 to $122,000. The position may be eligible for a role-specific discretionary bonus, relocation, and/or other compensation elements.