Associate Director, Engineering (San Carlos, CA)
Sutro Biopharma, Inc. is looking for an energetic and talented professional to join its Engineering & Facilities Team. The E&F Team is responsible for new equipment installation, equipment modification and upgrades, manufacturing support (Investigations, Change Controls, CAPAs) and equipment & automation modification qualification. 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 at Sutro’s Manufacturing site in San Carlos, CA.
The Associate Director, Engineering, E&F will support manufacturing of XpressCF+ platform and protein purification process at Sutro’s Manufacturing site. The associate director will provide direct engineering support at Sutro’s San Carlos facility. This includes serving as the engineering owner.
Primary responsibilities will include but not limited to:
- Provide technical knowledge to support clinical drug intermediate/substance production at Sutro manufacturing site, including specification of equipment & automation requirements, monitoring, analysis, troubleshooting.
- Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements.
- Collaborate with Manufacturing, MSAT and Facilities focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug substance manufacturing technologies into our facility.
- Drive or support completion and evaluation of investigation for discrepancies/deviations, facility/equipment changes and optimization, and regulatory submissions.
- 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.
- BS or MS in Chemical/Mechanical Engineering, or Biological Sciences, or relevant field.
- 10+ years work experience in cGMP biopharmaceutical production setting (Process Development and/or Manufacturing technical support).
- Experience in large-scale biopharmaceutical manufacturing process, as applied to fermentation, purification processes, spray drying and associated formulation operations.
- Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements.
- Familiarity with Upstream and Downstream unit operations, Clean Utilities a plus.
- Self-motivated, able to work independently as well as in teams.
- Excellent organization and communication skills (both written and verbal).
- Ability to exercise independent judgment and discretion regarding matters of importance and to problem solve in creative ways.
- Ability to support meetings within the Sutro partner/CMO network (early morning/late evening), as needed.
- Project management experience.
- People management experience.
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.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be [$160,000 – $180,000] (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.
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.