Director, Upstream 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.
- Oversee internal manufacturing and support transfer out to external manufacturing to Contract Development and Manufacturing Organizations (CDMO).
- Responsible for launching our manufacturing processes globally in all processes from fermentation through bulk intermediate for our entire portfolio of cell free platform based products.
- Work with internal and external resources to ensure manufacturing schedules meet requirements for aggressive product launch schedules that meet corporate objectives.
- Participate in defining strategic manufacturing goals and objectives.
- Assist in creating the vision and help establish the strategic manufacturing goals and budgets that ensure linkage to the business strategy.
- Develop a strategy for manufacturing through first customer shipment using internal manufacturing resources as well as CDMOs.
- Lead cultural and organizational change, implement operational excellence and lean manufacturing for continuous improvement of competitiveness and financial performance.
- Lead the design of pilot scale facilities and equipment required to help Sutro scale-up into commercial manufacture.
- Implement the appropriate team and departmental structure and establish the required processes and communications to enable the department to effectively deliver on all commitments.
- Build strong relationships with CMOs for accelerated advancement of our early commercial products as well as pipeline programs.
- Participates in and generates updates for weekly executive level, cross departmental manufacturing review meetings with sourcing, supply chain, quality, and various manufacturing stakeholders.
- Participates in forward-looking global manufacturing capacity review so that sourcing has time to find multiple leads with time to get competitive bids.
- Provide expertise to sourcing / capex team on process requirements for CMO selection and process / capacity requirements.
- Build a high performing organization, capable of agility and ingenuity on fast-moving projects.
- Responsible for talent management (recruitment, development and retention) in the manufacturing department.
- Lead and facilitate the implementation of new systems, software, policies and procedures.
- Manage external contractors and consultants to successfully achieve production and validation goals.
- Oversees and coordinates the day-to-day safety, activities, and work schedules of any internal lab /manufacturing operations.
- Models continuous improvement behaviors for all employees, especially with regard to quality issues, team relations, on-time work execution, and customer satisfaction.
- Trains, or coordinates training of team members in the most effective execution of work procedures.
- Responsible for cGMP compliance, where appropriate, by defining, implementing and maintaining appropriate SOP’s and training.
- BS/MS or PhD in Chemical or Biochemical Engineering or Biological Sciences or relevant field.
- 20 + years for B.S/M.S (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 fermentation processes (harvest-depth filtration, chromatography, filtration, ultrafiltration diafiltration and conjugation 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).
- 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. 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 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.
Please be advised, inquiries or resumes from recruiters will not be accepted.
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.