Responsible for supporting operations in the Oceanside Pilot Plant and Science and Engineering Purification/Analytical Lab. Deliverables include but are not limited to: HPLC-based analytics, rapid bioburden/endotoxin, lab scale and pilot scale chromatography, UFDF operations, buffer prep, column packing, equipment maintenance and preparation of technical reports. May commission new equipment, troubleshoot equipment and systems, develop new equipment requirements and operating parameters, and provide factory and site acceptance testing. Provide scientific and technical support to GMP Manufacturing Operations in a multi-product, large scale, automated biopharmaceutical facility. Support process validation through large and small-scale studies, protocol and report preparation, validation sampling, and sample shipments.
Will contribute to the daily operations in the Oceanside Process Engineering (PE) pilot plant and/or analytical laboratory
Assist with the tech transfer of new products to Oceanside
Implement new purification processes and analytical methods into PE pilot plant and analytical lab
Perform pilot-scale studies as needed to support commissioning and optimization of the manufacturing scale and purification process tech transfers
Perform analysis of in-process intermediates and raw materials using HPLC, rapid bioburden and endotoxin, particle analysis, and small-scale protein purification and filtration for a variety of purposes, including investigations, process validation, process development/ improvement and routine testing.
Assist with the factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of S&E pilot plant equipment
Prepare area SOPs
Monitor small scale and large scale cell culture or purification processes to identify and resolve complex equipment and process issues
Contribute to process validation/characterization efforts, including but not limited to: large and small-scale studies, protocol and report preparation, validation sampling, and sample shipments.
Contribute to advances in technological capabilities
Provide technical support for all associated Make-Assess-Release activities, including monitoring, trouble-shooting, corrective action and assessment and remediation of discrepant incidents impacting manufacturing materials, methods and equipment.
Support implementation of manufacturing continuous improvement initiatives and support of New Product Introduction (NPI)
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.
May act as Subject Matter Expert for the purposes of training S&E personnel
Embraces open communication, teamwork and transparency by aligning efforts and knowledge sharing
Gathers data on campaign material consumption and creates detailed material requirements
Communicates changes for site logistics and planning functions to ensure correct inputs for
Bachelor's or Master's degree in Engineering or Life Sciences.
4-6 years experience in relevant field.
2-4 years with Master
Proven knowledge and practical experience with core regulatory requirements
Demonstrated working knowledge of process control, manufacturing execution and enterprise resource planning systems.
Proven management, communication, interpersonal, organizational and project management skills.
Demonstrated ability to work as part of a multi-disciplinary team.
Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.
Ability to interact within and across work groups and with outside collaborators and vendors on technical matters.
Demonstrated technical proficiency, leadership, creativity, and strategic thinking.
Practical and theoretical expertise in biopharmaceutical manufacturing processes engineering and applied technologies.
Strong oral and written communication skills.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
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At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.