Senior MSAT Engineer (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 ideal candidate will be supporting technology transfers of cell-free production processes (fermentation and downstream purification processes) in close collaboration 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 be based in Sutro’s San Carlos, CA Manufacturing site.

Responsibilities

  • Oversee internal manufacturing and support process technology transfer to external Contract Development and Manufacturing Organizations (CDMO)
  • 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.)
  • Drive process monitoring programs for the fermentation and purification areas (e.g. critical processing parameter monitoring, chromatography performance assessment metrics and integrity, process impurity removal performance, equipment cleaning verification/validation, and cross contamination assessments)
  • Author and review manufacturing documents (i.e. batch records, SOPs, and deviation reports, etc.) and summary reports working with quality systems (QS, QA and QC) on product release
  • Collaborate with Procurement, Development, and Quality Assurance to ensure timely material generation requirements and procurement to fill the need for GMP production
  • Participate in external tech transfer of fermentation and purification processes as it relates to CDMO selection, facility fit, gap assessments, comparability protocol generation and development of fermentation and purification success criteria
  • Work with internal and external resources to ensure manufacturing schedules meet requirements for aggressive product launch schedules that meet corporate objectives
  • Support the implementation of operational excellence directives and lean manufacturing for continuous improvement of competitiveness and financial performance
  • Support the improvement of pilot scale facilities and equipment required to help Sutro scale-up into commercial manufacture; for both today and the future
  • Support the building of strong relationships with CMOs for accelerated advancement of our early commercial products as well as pipeline programs
  • Provide expertise to sourcing / capex team on process requirements for CMO selection and process / capacity requirements
  • Lead and facilitate the implementation of new systems, software, policies and procedures related to biologics manufacturing
  • Support the management of external contractors and consultants to successfully achieve production and validation goals
  • Models continuous improvement behaviors for all employees, especially with regard to quality issues, team relations, on-time work execution, and customer satisfaction
  • Responsible for cGMP compliance, where appropriate, by defining, implementing and maintaining appropriate SOPs and training

Qualifications

  • BS/MS or PhD in Chemical or Biochemical Engineering or Biological Sciences or relevant field
  • 12+ years for B.S/M.S (or 8+ 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 fermentation processes (includes bioreactor preparation and running, harvest-depth filtration, chromatography, filtration, ultrafiltration/diafiltration and conjugation operations) – in addition to scale-up/scale-down principles of biochemical engineering, and process data analysis
  • A thorough understanding of cGMP requirements is required
  • Experience in 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
  • 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 is a requirement

Sound exciting? Apply today and join our team!

Please submit resume for Req. #2294 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.