Director, Purification MSAT (San Carlos, CA)

Sutro Biopharma, Inc. is looking for an energetic and talented professional to join its MSAT Group. MSAT Group responsible for technology transfers, manufacturing support (investigations, change controls, CAPAs, process capability/monitoring/capacity/efficiency/quality improvements) and process validation. The ideal candidate will be supporting technology transfers of cell-free production process 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

The Director of Purification MSAT will oversee internal manufacturing and support transfer out to external manufacturing to Contract Development and Manufacturing Organizations (CDMO).

The Director will lead the Downstream process scale up from internal process development to GMP manufacturing process at internal and external CDMO sites for harvest and filtration, different chromatography techniques, ultrafiltration and diafiltration, formulation and final fill.

Primary responsibilities will include but not limited to:

• Drive focus on Manufacturing Process Scale-Up and technology transfer.
• Drive completion and evaluation of investigation for discrepancies/deviations, process changes and optimization, and regulatory submissions.
• Partnering with Process Development for lab work may be required to resolve investigations and/or demonstrate proof-of-concept for proposed process changes.
• Support process validation activities.
• Take full accountability of Make/Assess/Release of all GMP campaigns (Internal and External) with respect to assessment of campaign readiness/run support/performance assessment and closure of all quality records.
• Support development of material specification, process/equipment risk analysis and GMP documentation are required for GMP runs.
• Design testing protocols for process scale up in Sutro’s manufacturing facility prior to GMP manufacture, expertise on downstream chromatography system (e.g., AKTA Avant/Pilot/Ready/Process), TFF system, and various depth filtration techniques, proficiency in UNICORN is a plus.
• Develop process models and schematics for all purification steps that includes buffer consumption, cycle times, pool volumes, samples etc.
• Drive process monitoring program for the purification area (e.g., chromatography performance assessment metrics, Column integrity, impurity removal, cleaning verification/validation, and cross contamination assessments).
• Author and review manufacturing documents (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 the purification process as it relates to CDMO selection, facility fit, gap assessments, comparability protocol generation and development of purification success criteria.
• Develop process controls for impurity removal, and critical quality attributes (CQA) control in conjunction with Process Development.
• Have a strong focus on data analysis and trending tools, proficiency in JMP is a plus.
• Responsible for the management, performance, and development of the purification MSAT team members.
• Develop robust process data templates and draft annual process monitoring reports to track/trend process performance across multiple sites.
• Be a strong proponent of continuous improvement aspects for all employees, especially regarding quality issues, team relations, on-time work execution, and customer satisfaction.
• Responsible for cGMP compliance, where appropriate, by defining, implementing and maintaining appropriate SOP’s and training.

Qualifications

• BS/MS or PhD in Chemical or Biochemical Engineering or Biological Sciences or relevant field.
• 20+ years for BS/MS (or 15+ 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 and associated formulation 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).
• 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 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 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.