Executive Director, Upstream Process Development

Sutro Biopharma, Inc is looking for an inspiring technical leader who will play a key role to drive and lead the process development of Sutro pipeline projects, with a focus on defining late-stage strategy for our novel cell-free protein synthesis platform. As a member of the Upstream Process Development Leadership Team, serving as a key technical and CMC leader for the ongoing Sutro pipeline projects in various development lifecycles.  A key responsibility of the candidate is to develop holistic late-stage strategies that contribute to the Sutro Cell-free platform.  This individual will have full ownership of developing strategy including (but not limited to) risk assessment, upstream process characterization, approach to the control strategy, and carry through into the final stage of PPQ .  You will work with the senior members of the upstream process development team, together with cross functional teams, to implement the defined strategy into practice, supporting upcoming late-stage program(s). You will also participate in a cross-functional CMC teams to influence and align the upstream late-stage strategy with the rest of the organization. Opportunities to engage with regulatory agencies to finalize the late-stage strategy will also be part of the responsibility of this role. This role will report to the Chief Technical Operations Officer.  Responsibilities: 

• Responsible for leading and directing all aspects of upstream process development (pre-IND to commercial), including strain development, fermentation, cell-free synthesis, and microbial extract spray drying processes, process characterization and process validation-supporting activities. Lead, motivate, and develop technical staff
• Develop responsible budgets for department to manage effectively to meet company financial goals
• Take a lead role in defining the late-stage strategy for the Sutro’s Cell-Free Protein Synthesis platform. This will encompass all upstream processes leading up to the Cell-Free process, including plasmids, our custom reagents and extract processes
• Serve as a technical/CMC leader to drive upstream process development of Sutro pipeline projects in various development lifecycle
• Write and/or review relevant CMC sections of regulatory submissions (DMF, IND, BLA) and collaborate closely with Regulatory Affairs-CMC to define CMC strategy for Upstream activities
• Develop new workflows and templates to support the various tasks during late-stage development, such as risk assessment, scale-down model development/qualification, and process characterization
• Transfer upstream processes to Sutro manufacturing site and/or partner sites
• Set long-range strategies for technology development, including IP management to ensure FTO
• Represent Upstream Process Development on cross-functional teams
• Serve as CMC/Technical Lead in CMC programs 
• Serve as a key stakeholder in the various CMC teams to drive, inform, and align the defined late-stage strategy with the rest of the organization
• Represent Sutro in due diligence activities to enable partnerships.
• Produce significant documents, position papers or publications (internal/external) supporting company policies and goals
• Work with other teams and external consultants to develop an end-to-end validation plans that are appropriate for the Sutro’s Cell-Free platform
• Work with and guide the various upstream sub teams to implement the defined strategy into all the respective projects
• Support all the necessary steps toward successful PPQ campaigns
• Author relevant sections of briefing packages required for CMC engagement with regulatory agencies in the various regions of the world
• Participate in regulatory agency engagement to discuss late-stage strategy for the Sutro cell-free platform
• Serve as a late-stage SME to the rest of the organization to incorporate late stage concepts early in process development lifecycle in an effort to gain efficiency in future projects
• Present to senior management and at conferences; exert influence inside and outside Sutro through publications and meeting participation

  Qualifications: 

• B.S., M.S., or Ph.D. in chemical engineering, life sciences, or equivalent with at least 25 years (B.S., M.S.) or 20 years (Ph.D.) of biopharmaceutical industry experience in microbial fermentation/cell culture process development and optimization. Knowledge of upstream process effects on product quality expected and 3-5 years of practical experience in late-stage process development is a must.
• Experience with statistical design of experiments, advanced data analysis, and Quality by Design concepts is expected.
• Extensive experience in scaling up and transferring fermentation/cell culture processes to pilot and/or commercial scale and demonstrated business acumen
• Experience with regulatory engagements and BLA authoring is preferred.
• Detail oriented with good organizational and collaborative skills and prior success working in a high paced team environment to meet deadlines and prioritize work on multiple projects.
• Proven track record of excellent communication, both verbal and written, and the ability to build and maintain relationships with partners, customers, and collaborators.

 Sound exciting? Apply today and join our team! Sutro Biopharma, Inc. encourages 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.  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. The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be [$295,000 - $315,000] (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education. 

  

About Sutro Biopharma  Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.