What are the responsibilities and job description for the Master MFG Associate, Upstream, Fremont CA position at BI Fremont?
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. Serves as an operations subject matter expert (SME) representing the department during audits, new product introductions, and technical assessments. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees
Duties & Responsibilities
- Independently executes complex unit operations including but not limited to batching and inoculation of bioreactors, operation of bioreactors, process monitoring, and harvest operations. Supports equipment and process troubleshooting and implements continuous improvement projects of low to moderate complexity in the production areas. Defines user requirements for new equipment and validation protocols.
- 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. Conducts group trainings on complex topics and scientific principles as needed.
- Contributes to Quality activities as investigations and area walk-throughs.
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.
- Strong working knowledge of biopharmaceutical manufacturing practices, as well as a strong understanding of biologics principles are 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.
Compensation Data