Senior Process Engineer
Sutro Biopharma is looking for a Senior Process Engineer within the BioMSAT group, with responsibility for specifying manufacturing process requirements, monitoring and analysis of manufacturing process data, and analyzing process and facility capabilities to identify improvement opportunities.
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 Fermentation or Purification bioprocess operations. Expertise in bispecifics/ADC molecules is ideal. Proficiency in data acquisition and analysis techniques and a willingness to learn new techniques is desired. Knowledge of the following software is desirable: OSI PI (and associated client tools), SuperPro Designer, Visual Basic, SAS JMP.
- Provide process technical leadership to support clinical drug substance production at Sutro manufacturing site/CMOs, including specification of process requirements, monitoring, analysis, troubleshooting, and developing process models for various pipeline products.
- Make/Assess/Release (MAR) campaign support – Ownership of Change Controls, Deviations and CAPAs to support lot release. Provide a science-based approach for resolution of deviations, investigations, and process issues through analysis of historical data and development studies.
- Authoring and/or review technical documents related to technology transfer, process monitoring, at-scale studies, and non-conformance (deviations/investigations) to support process transfer and ongoing manufacturing.
- Contribute to the design, formulation, review, and implementation of fermentation/purification manufacturing recipes, SOPs, and associated process documents.
- Lead or participate in equipment validation and technology transfer activities, as well as partner/QP audits.
- 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.
- Serve as site representative on cross-functional teams including site project/ operation teams, technology transfer teams, to define and implement product-focused strategic initiatives.
- Collaborate with manufacturing, quality, process development and regulatory organizations to establish a reliable state of manufacturing process control.
- Keep abreast of industry best practices, and evaluate potential application within organization, as applicable.
- In addition to core responsibilities, the successful candidate may be asked to perform additional technical assignments.
- BS/MS or PhD in Chemical or Biochemical Engineering, 12 + years for B.S (or 10+ years for MS or 5+ years for PhD) work experience in cGMP biopharmaceutical production setting (process development and/or manufacturing technical support)
- Experience in large-scale biopharmaceutical manufacturing process, as applied to fermentation processes (E.coli fermentation, centrifugation harvest, lysate clarification etc.) or purification processes (harvest-depth filtration, chromatography, filtration, ultrafiltration diafiltration and conjugation operations) – including scale-up/scale-down, principles of biochemical engineering, and process data analysis
- Full understanding of cGMP 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 exercise independent judgment and discretion regarding matters of importance and to problem solve in creative ways. Excellent written and verbal communication skills
- Ability to support international meetings within the Sutro partner/CMO network (early morning / late evening)
- Ability to travel to support technology transfers within continental U.S and Internationally.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
Please be advised, inquiries or resumes from recruiters will not be accepted.