Sutro Biopharma, Inc. is looking for an energetic and talented individual to join our Manufacturing Team. As a Manufacturing Manager you will support manufacturing operations by overseeing and performing a variety of activities with general guidance and in accordance with current GMPs while ensuring safety of the people, products, equipment, and facilities.
- Provides strategic direction for the Manufacturing organization and is a standing member of the Manufacturing Leadership Team.
- Mentors, coaches, trains, recognizes, and performance manages, as appropriate.
- Participates in the technology transfer, planning, implementation, and maintenance of manufacturing processes and procedures.
- Oversees and performs on-the-floor manufacturing operations, as needed.
- Creates, reviews, and approves batch records, standard operating procedures, media/buffer tickets, and forms.
- Subject Matter Expert (SME) on manufacturing processes and equipment.
- Leads and participates in cross-functional teams.
- Authors and contributes to the closure of quality records.
- Ensures training records for staff are accurate and current.
- Interacts with senior management and outside vendors.
- A minimum of a B.S. Degree in the biological sciences or engineering with seven (7) or more years of experience and one (1) or more years in a leadership or equivalent role in a current Good Manufacturing Practices (cGMP) environment is required.
- Must be knowledgeable of cGMPs and possess a cGMP, compliance, and technical mindset.
- Working knowledge of chromatography, tangential flow filtration, filtration, and buffer/media preparation operations and equipment. Spray dryer experience a plus.
- Understand process, systems, and equipment to troubleshoot issues and provide solutions.
- Experience in resolving production non-conformances/deviations, implementing corrective and preventative actions, leading improvement projects and initiatives, and validating systems/processes.
- Possess strong leadership, organizational, and technical skills.
- Possess strong verbal and written 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.
Please be advised, inquiries or resumes from recruiters will not be accepted.