The Mfg. Sciences Purification (MS Pur) group is dedicated to providing scientific and technical support to Vacaville drug substance manufacturing operations, from harvest through formulation and storage. The MS Pur group works in collaboration with Manufacturing, Process Development, Quality, and other technical and business functions in order to ensure efficient and safe drug substance manufacturing processes for the production of multiple recombinant proteins. MS Pur is responsible for process monitoring and analysis, receiving new processes from Process Development or other manufacturing sites, process performance troubleshooting, maintenance of the process validated state and ongoing process improvement. MS Pur pursues scientific excellence and employee development in achieving its goals.
The open position is for Process engineer within the MS Pur group, with responsibility for monitoring and analysis of manufacturing process data, execution of full-scale process validation and technical oversight of scale down (laboratory) experiments, to enable efficient transfer and stewardship of downstream processes.
Specific responsibilities for this position will include (but are not limited to):
Site Technical steward of the purification process, including specification of process requirements, monitoring, analysis, troubleshooting, and maintenance of the process validated state. Contribute to the design, formulation, review, and implementation of purification manufacturing formulae, SOPs, and associated process documents. Design and execute studies at manufacturing scale to establish and maintain the process validated state. Authoring and review of technical reports and assembly of technical information to support process transfer and ongoing manufacturing Provide guidance to junior staff in the group. Provide technical leadership and support other groups (i.e. regulatory and quality) for investigations, product impact assessments to support investigations and changes, inspections, CAPAs, and other quality commitments. Participate in the design and technical oversight of laboratory experiments in support of plant operations, troubleshooting, process transfer, process improvement and process understanding. Participate or lead new technology evaluation. Contribute to the supporting data necessary for change implementation. Interact with planning and manufacturing groups to execute process improvement projects Contribute to network teams dedicated to process stewardship, purification process validation and unit operation best practices.
In addition to core responsibilities, the successful candidate may be asked to perform additional technical assignments.
- BS or higher degree in Chemical or Biochemical Engineering.
- Minimum of 8 years for B.S (or 5 years for MS or 1-2 years for PhD) work experience in cGMP biopharmaceutical production setting (process development and/or manufacturing technical support)
- Sound background in large-scale processing, thorough understanding of biochemical and engineering fundamentals as applied to purification processes (harvest, chromatography, filtration and ultrafiltration diafiltration operations), including scale-up/scale-down
- Knowledge of GMP documentation requirements
- Proficiency in statistical and multivariate data analysis techniques
- Self-motivated, able to work independently as well as in teams. Excellent organization and communication skills (both written and verbal)
- Demonstrated experience in leading cross-functional teams responsible for the implementation of technical changes / process improvements
- Ability to support international meetings within the Roche network (early morning / late evening)
The ideal candidate will have a general knowledge of the underlying scientific principles applied to the development and manufacture of biopharmaceuticals, and a keen interest in downstream bioprocess operations. Proficiency in data acquisition and analysis techniques and a willingness to learn new techniques is desired. Knowledge of the following software is also helpful: OSI PI (and associated client tools), ORACLE, R, Visual Basic, SAS JMP.