Senior Engineer, Data Science, MSAT (San Carlos, CA)

Sutro Biopharma, Inc. is looking for an energetic and talented professional to join its MSAT Group. The MSAT Group is responsible for technology transfers, manufacturing support (investigations, change controls, CAPAs, process capability/monitoring/capacity/efficiency/quality improvements), authoring regulatory documents, supporting regulatory/compliance audits and process validation. The MSAT team is starting a Data Science team which will do the following:

  • Plan, create, deploy, and support manufacturing process data analytics and digital transformation
  • Perform process statistics, process models, Cost of goods assessments
  • Drive annual process monitoring protocols and reports. Identify trends using SPC tools/methods
  • Aid in making data- driven decisions for process investment using simulation tools such as Monte Carlo/Crystal ball

We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team. This full-time onsite position will be based in Sutro’s San Carlos, CA Manufacturing site.

Responsibilities

  • Drive the implementation of data trending program for all products manufactured at Sutro’s internal manufacturing site and at Sutro’s CMOs
  • Drive process monitoring programs for the fermentation and purification areas (e.g. critical processing parameter identification and monitoring, chromatography performance assessment metrics and integrity, process impurity removal performance, equipment cleaning verification/validation, and cross contamination assessments)
  • Implement tools and software for lot tracing, process data gathering, run performance analysis
  • Provide expertise in programming (Python) and database management (SQL)to streamline complex manual data entry, linking data from segregated process units
  • Provide expertise in data analysis/modeling software (PIMS, MATLAB, Ansys, Solidworks, Comsol, SuperPro, SIMCA etc.) and visualization tools such as tableau, Spotfire, PowerBI, etc.
  • Drive the Annual Process Monitoring program for Sutro (APQR) and relay trends using SPC and aid with investigations
  • Develop, review and/or approve protocols and reports containing significant statistical content.
  • Contribute to the development and implementation of next gen process monitoring tools and implementation of Process Analytical technology (PAT)
  • Assist with integration of data from islands of automation in manufacturing and frame a platform for visualization, reporting and analysis
  • Develop or adapt to existing and innovative methods and techniques for data collection, data configuration, data analysis and/or data modeling, to continuously increase effectiveness and contribute to process improvement
  • Ensure proper compliance with legal standards, regulations and guidance published by FDA, ICH, EMA and other regulatory groups, to contribute to high-quality scientific/technical reports and documents and strive for optimal quality of methods/techniques in accordance with agreements, guidelines, and regulations
  • Excellent grasp to develop scripts for statistical software (JMP, Minitab)
  • Train fellow colleagues, maintain, update, and communicate knowledge of statistical methods and techniques
  • Support the development of process models and schematics for all fermentation and purification steps (i.e. monitoring of fermentation critical processing parameters and downstream processing steps such as buffer consumption, cycle times, pool volumes, samples etc.)
  • Model continuous improvement behaviors for all employees, especially with regard to quality issues, team relations, on-time work execution, and customer satisfaction
  • Be responsible for cGMP compliance, where appropriate, by defining, implementing and maintaining appropriate SOPs and training
  • Drive internal project for converting data in paper batch records into an electronic repository

Qualifications

  • B.S/M.S (PhD is a plus) is required, preferably in one of the following disciplines: data sciences, statistics, bio-informatics, Engineering or a similar field of study
  • A minimum 5+ years’ pharmaceutical industry experience
  • Experience developing data analytics solutions for biologics processes
  • Master statistical techniques, complex statistical analyses (including multi-variate), data configuration and/or data modeling techniques
  • Experience with statistical and database management software such as JMP, R, Python, Statistica, MATLAB, SIMCA, SQL, Oracle, etc.
  • Fluency to interpret complex data patterns and communicate conclusions in written and oral format
  • Experience in leading complex technical substantive projects
  • Experience in mentoring or training colleagues

Sound exciting? Apply today and join our team!

Please submit resume for Req. #2299 to jobs@sutrobio.com. Please visit our website at www.sutrobio.com for more information.

Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Sutro will consider requests for reasonable accommodations.

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.

We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.

Company Overview

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.