Director, Upstream Process Development (South San Francisco, CA)

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. The successful candidate will be part of the Upstream Process Development Leadership Team, serving as a key technical and CMC leader for the ongoing Sutro pipeline projects in various development lifecycle.  A key responsibility of the candidate is to develop a 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 Senior Director of Upstream Process Development.

Responsibilities

• Serve as a technical/CMC leader to drive upstream process development of Sutro pipeline projects in various development lifecycle.
• 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.
• 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.
• 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.
• 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.
• 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.
• Drive results and report progress to management and major stakeholders
• 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.

Qualifications

• B.S., M.S., or Ph.D. in chemical engineering, life sciences, or equivalent with at least 15 years (B.S., M.S.) or 8-10 years (Ph.D.) of biopharmaceutical industry experience in microbial fermentation/cell culture process development and optimization. 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. 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.

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 $200,000 – $230,000 (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.

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.  For more information, please visit www.sutrobio.com