Senior Process Engineer, MSAT
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.
Sutro Biopharma, Inc. is looking for an energetic and talented professional to join its MSAT Group. Our MSAT group is responsible for technology transfers, manufacturing support (investigations, change controls, CAPAs, process capability/monitoring/capacity/efficiency/quality improvements) and process validation. The ideal candidate will support our purification process in closecollaboration with cross-functional departments and play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.The position will operate inside Sutro’s Manufacturing site in San Carlos.
- 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 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 Biological Sciences or Chemical or Biochemical Engineering.
- Senior Process Engineer: 10 + years for B.S (or 5+ years for MS or 2+ years for PhD) work experience in cGMP biopharmaceutical production setting (process development and/or manufacturing technical support)
- Principal Process Engineer: 12 + years for B.S (or 7+ years for MS or 4+ 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 e.coli 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
- Experience leading a drug candidate into PPQ/commercialization is ideal with thorough understanding of cGMP requirements.
- Experience drafting/revising regulatory documents (IND/BLA/DMFs) and support of Health Authority and Partner audits is a plus.
- 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.
Sound exciting? Apply today and join our team!
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.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
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.