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About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Manager, Cell Therapy Manufacturing you will report to the Exec. Director, Manufacturing Site Start-Up Lead, to build the manufacturing team and lead manufacturing start-up activities. You will be at the forefront of delivering new capabilities for the organization by being a critical component in starting up Sana’s first manufacturing site. In this capacity, you will define the way Sana runs manufacturing going forward as well as build new relationships with amazing internal partners as well as external.

What you’ll do

• Build manufacturing team at Bothell site.
• Manage the creation, implementation and compliance for all documentation, procedures and policies.
• Develop and manage implementation of training curricula
• Build an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
• Plan, assign and oversee daily operational activities.
• Identify strategic and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation responses and investigation.
• Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner in accordance to schedules and defined implementation timelines
• Oversee operators on daily basis as they:
  • Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner.
  • Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
  • Maintain training assignments to ensure the necessary technical skills and knowledge.
  • Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities.
  • Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Hire, mentor and develop exceptional people.
• This position will require shift work, including holidays and weekends.
• This position will require working in a clean room environment, with exposure to human blood components.
• Maintain current state of training with cGMP SOPs.
• Engage in strategic and purposeful discussions to ensure stakeholder alignment when executing maintenance and calibration activities
• Influence decision making on facilities and equipment within the purview of maintenance and calibration.
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• Bachelors in relevant science or engineering discipline or equivalent in work experience
• 7+ years of relevant cGMP manufacturing experience
• 3+ years in cell therapy manufacturing
• 3+ years of experience with managing a group of 3 or more people
• Excellent verbal and written communication skills with understanding of documentation requirements

What will separate you from the crowd

• Experience with site start-up activities from the beginning (as one of the first hires of the team).
• Experience interacting with regulatory agencies.
• Experience with leading and implementing lean manufacturing methodologies

What you should know

• Position is located in Bothell, WA
• The base pay range for this position at commencement of employment is expected to be between $130,000 and $160,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience