• Executes, with oversight of qualified staff, complex unit operations including but not limited to chromatography operations, tangential flow filtration, various filtration methods, and process monitoring.
• 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 weigh 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.
• 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 as investigations and area walk-throughs.

Master Associate Requirements

• High school degree plus minimum four (4) year's work experience in GMP regulated industry
• Associates/Bachelor's degree from an accredited institution or biotechnology vocational training preferred.
• Four (4) 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.
• Subject Matter Expert of biopharmaceutical manufacturing practices, as well as a high technical knowledge of biologics principles required.
• 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.

Associate Requirements

• High school degree plus minimum one (1) year work experience in GMP regulated industry
• Associates/Bachelor’s degree from an accredited institution or biotechnology vocational training preferred.
• One (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.
• Basic knowledge of fundamental manufacturing concepts is preferred. Does not require extensive technical knowledge of 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.

Sr Associate 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.
• Two (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.
• Strong working knowledge of fundamental manufacturing concepts is required. Moderate technical knowledge of biologics operations is preferred.
• 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.