Sutro Biopharma, Inc. is seeking an experienced Manager/Senior Manager, Supply Chain who will coordinate CMO activities within a multi-functional team environment to support clinical phase GMP programs. Primary responsibilities will involve oversight and management of outsourced clinical supply activities including process and analytical technology transfer, initial production, and ongoing supply of custom reagents and raw materials, intermediates, drug substance, and drug product. The ideal candidate will be highly organized and action-oriented, with excellent verbal and written communication skills and demonstrated success in relationship building, influence management, and collaboration. In addition, hands-on experience with technology transfer and production operations for small molecules and/or biologics is required.
- Serve as primary contact with CMO for defined projects, maintaining good collaboration and professional relationships while driving project success.
- Oversee and manage technology transfer of well-defined processes (both small molecule and biologics) to external Contract Manufacturing Organizations (CMOs).
- Oversee and manage initial production and continued supply of cross-program custom materials (small molecule).
- Establish and maintain systems for supply (tracking and planning) of cross-program custom materials.
- Provide on-site support for CMO manufacturing activities, including real time communication with management and Quality.
- Represent Supply Chain on multi-functional project teams.
- Work cross-functionally with Development, Analytical, QC, and QA departments to ensure timely support for outsourced programs.
- Pro-actively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in outsourced programs.
- Communicate project status both verbally and through written documents and reports.
- Participate in preparation of RFPs, contract negotiation, and budget preparation.
- Possibility to liaison with partners for partner projects
This individual will be expected to effectively follow Sutro Biopharma’s SOPs and policies, and cGMP compliance regulations.
- BS or MS degree in Chemistry/Biochemistry/Engineering or related field.
- 6-10 years hands-on experience in a biotech environment.
- Experience working with and/or managing contract manufacturing organizations is strongly preferred.
- Working knowledge of antibody, antibody drug conjugates and/or small molecule processes and analytical methods is desirable.
- Hands-on management of custom supply including tracking and planning is desirable.
- Skilled in using influence management to drive project success.
- Demonstrated ability to work accurately, meet timelines and handle multiple priorities.
- Capable of responding flexibly to changing prioritization in a dynamic environment.
- Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner.
- Strong verbal and written communication skills essential.
- Requires working knowledge of cGMP and regulations applicable to the FDA and comparable international regulatory agencies.
- Project management and/or business experience a plus
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.