Sutro Biopharma, Inc. is looking for a Technology Transfer Leader accountable for the seamless transfer of new processes and molecules from Development to the Manufacturing Plant. SME for the Manufacturing Plant for interactions with Regulatory agencies and Alliance Partners.
- Represent manufacturing as member on the CMC team to ensure manufacturing is integrated in the overall CMC plan for all phases of the project from early development through commercial launch.
- Establish technology transfer processes with PD, AD, QC, and Manufacturing to ensure successful execution of manufacturing campaigns to support clinical programs.
- Lead technical process improvement through Statistical Process Control Methodology
- Lead teams comprised of PD, AD, Engineering, Manufacturing, Materials & Logistics, QC, and QA to implement fully integrated manufacturing processes.
- SME and leader for process trouble shooting and deviation resolution for production batches.
- SME of manufacturing process for writing manufacturing sections of the BLA and for Regulatory inspections.
- Participate with Supply Chain and Materials & Logistics in capacity analysis and long-term manufacturing strategy.
- Lead projects focused on process understanding including process modeling and data trending.
- Develop an integrated Process Engineering plan to develop equipment understanding and compatibility for current and future manufacturing processes.
- Assistance in selection of CMOs for support of late-stage clinical trials and RM manufacture.
- PhD biochemist or biochemical engineer with 8-10+ years or MS with 12-15+ years of small scale and pilot plant process development experience.
- Demonstrated experience in establishing and leading a biopharmaceutical manufacturing group.
- Experience with microbial manufacturing operations including cGMP operations and transfers of technology to CMOs.
- Familiar with process development, validation and technology transfer to manufacturing.
- Demonstrated ability to troubleshoot processes once they have been transferred to manufacturing.
- Willing to participate hands on in the start-up of a group.
- Must have strong management and leadership skills.
- Proven experience leading a multi-disciplinary team
- Ability to manage people in a fast paced environment.
- Must possess good communication skills (verbal and written) and good interpersonal skills.
- Familiar with budgeting processes for projects, personnel and equipment.
- Knowledgeable about the concepts related to Quality by Design and how to apply these concepts.
- Experience with Design of Experiments.
- Excellent organizational, computer, written and verbal communication skills.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.