Engineer/Scientist

Join our dynamic Oceanside Process Sciences team within the Manufacturing and Science Technology (MSAT) department, where innovation meets excellence in biopharmaceutical manufacturing. As a pivotal contributor, you will support critical operations across Upstream, Downstream, and Analytical small and pilot scale processes. Your role is integral to maintaining the cutting-edge standards of our automated, large-scale multi-product facility.

In this role, you will implement and optimize small and pilot scale operations, ensuring meticulous equipment maintenance, data analysis, and the preparation of comprehensive technical reports. You will spearhead the commissioning of new equipment, troubleshoot technical issues, develop advanced equipment requirements and operating parameters, and conduct rigorous factory and site acceptance testing. Additionally, you will provide expert guidance to GMP Manufacturing Operations, enhancing process validation through well-designed studies, meticulous protocol and report preparation, and efficient validation sample management. Driving the evaluation and implementation of new technologies will ensure our processes remain at the forefront of industry standards.

This role promises a blend of hands-on technical work, innovative problem-solving, and strategic scientific support, all within a collaborative and forward-thinking environment. If you're passionate about making a tangible impact in biopharmaceutical manufacturing technology, we invite you to be a part of our team.

The Opportunity

• Will contribute to the daily operations in the Oceanside Process Sciences (PS) small-scale, pilot plant and analytical laboratory.

• Assist with the tech transfer of new products to Oceanside:

  • Implement new cell culture/purification processes and analytical methods into PS small-scale, pilot plant and analytical lab.

  • Perform pilot-scale studies as needed to support commissioning and optimization of the manufacturing scale and purification process technical transfers.

• Perform analysis and studies of in-process intermediates and raw materials using small scale for a variety of purposes, including investigations, process validation, process development/ improvement and routine testing.

• Execute and lead small/pilot scale studies in close collaboration with customer and all involved groups to support: make-assess release, tech transfers, and network.

• Automation and Engineering solutions and act as a member of a high functioning team. These tasks will include those associated with coordinating and performing operations (i.e. set up, inoculating, maintaining, harvesting and cleaning equipment/bioreactors).

• Experiment data recording, collection, and analysis. He/she should be able to present information timely, clearly, and confidently.

• Lead tech transfers of phase III molecules from late stage process development to commercial launch scale and commercial scale to commercial scale: verification of scale-down model and site dependent/facility fit studies.

• Lead technical teams in support of site investigations and commercial make-assess-release.

• 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. Specific focus on continuous process improvement, new technology/process implementation and will design experiments and apply theories to execute projects.

Who you are

• Bachelor's, Master's, or Ph. D degree in Chemical/Biochemical Engineering or Life Sciences.

• 0-4 years' experience in relevant field.

• Knowledge in the area of biopharmaceutical manufacturing processes, including operational and technical troubleshooting skills, along with strong practical and theoretical expertise. Proven knowledge of core regulatory requirements and experience with process control, manufacturing execution, and enterprise resource planning systems.

• Project coordination/management, and strategic thinking skills, with the ability to take projects from idea inception to implementation. Strong organizational and problem-solving abilities, flexibility in work approach, and demonstrated initiative and accountability.

• Effective communication, interpersonal skills, and the ability to interact within and across work groups and with outside collaborators and vendors. Ability to work independently under limited supervision while being an integral part of a multi-disciplinary team.

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $80,500-$149,500.00 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.