Sutro Biopharma, Inc. is looking for an Manager, Manufacturing Operations experienced in Training Development, Technical Writing, Technology Transfer, Compliance, Project Management, and Operational Excellence initiatives to support Sutro Biopharma’s cGMP Manufacturing Facility in San Carlos. The ideal candidate will have hands-on experience in cGMP manufacturing and/or Quality Assurance. Specifically, experience in creating and implementing phase-appropriate systems for Training, Technology Transfer, and Compliance is desired.
The Manager, Manufacturing Operations will be a standing member of the Manufacturing Leadership Team, and be responsible for supporting operations in Sutro Biopharma’s cGMP Manufacturing Facility which will include:
Training Planning / Development
- Develops and implements a comprehensive and sustainable department-specific training approach that ensures staff can perform manufacturing operations in a safe, correct, and compliant manner. This includes, but is not limited to, defining role-based curriculum and the development and implementation of On-the-Job Training (OJT) procedures.
- Works with site Manufacturing Management to ensure consistency in training of floor staff on process operations, theory, and compliance.
- Provides oversight and drives accountably of Manufacturing-owned Quality Records (Deviations, Change Controls, and CAPAs) including timely initiation, execution, and closure through the development and maintenance of sustainable tools and processes.
- Partners with Technology Transfer and Manufacturing to ensure accuracy, consistency, and robustness of assigned documentation (eg SOPs, Production Batch Records, etc.).
- Drives visibility and progress of cross-functional campaign readiness deliverables to ensure run starts are compliant and on-time (eg Released documents are available, equipment is calibrated, etc.).
- Authors and oversees complex documentation creation and updates for new and current documents, respectively.
- Oversees the department-specific periodic review schedule to ensure all Manufacturing documents are accurate or revised as necessary.
- Partners with Manufacturing Management to ensure Inspection Readiness of all manufacturing areas.
- Manages audit findings (internal and external) to ensure timely completion.
Operational Excellence / Project Management
- Develops and maintains department-specific Key Performance Indicators (KPIs).
- Manages and improves business processes and practices to ensure documentation and processes are current, accurate, and efficient as applicable.
- Manages and supports continuous improvement initiatives and/or the implementation of projects and new business systems.
- Manages projects and key initiatives that directly support the Manufacturing Department and the overall success of manufacturing-related activities in San Carlos.
- Proficiency with Lean Six Sigma methodologies desirable.
- Requires a Bachelor’s degree in science and a minimum of 5+ years of related experience or Associate degree with 8+ years of related experience in Pharmaceutical / Biotechnology operations, including thorough working knowledge of cGMPs and compliance.
- Strong technical leadership, organizational planning, and project management skills.
- Must have strong oral and written communication skills.
- Must have strong interpersonal skills to help establish and maintain cross-functional work environment.
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.