Manager, Cell Manufacturing - iPSC

Role Summary

Manager, Cell Manufacturing (iPSC) — lead the establishment and operation of induced Pluripotent Stem Cell manufacturing, including building and managing the production team, overseeing facility and equipment start-up, day-to-day production, and supporting technology transfer from process development.

Responsibilities

• Build and lead a skilled cell manufacturing (iPSC) team, including hiring, onboarding, and mentoring staff
• Lead and support tech transfer activities for the startup of iPSC production; collaborate with process development and engineering teams to ensure smooth transfer of processes into production
• Supervise day-to-day activities of production team including scheduling and resource planning
• Monitor raw material usage and maintain accurate inventory levels for production
• Assist with the implementation and commissioning of new equipment and process changes
• Support routine equipment troubleshooting and optimization efforts
• Provide training and development of technical competencies across the team
• Create, review, and revise SOPs and manufacturing procedures
• Promote a culture of safety and ensure adherence to OSHA regulations and company safety policies
• Initiate and support investigations when process deviations or non-conformances occur
• Conduct performance evaluations, set objectives, and support career development through coaching, mentoring, and development plans
• Foster a collaborative and accountable team environment
• Deliver and document on-the-job training for new and current staff on production processes, equipment, and safety procedures
• Participate in department and corporate teams and initiatives
• Perform additional responsibilities as assigned by leadership

Qualifications

• Education and Experience requirements:
  • Bachelor’s degree in a directly related life science specialty field and 8+ years of related experience in life sciences, or
  • Master’s degree in a directly related life science specialty field and 6+ years of related experience in life sciences
• 2+ years of people management experience
• Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards; ability to apply GMP to company-specific processes and products
• Understanding of basic cell therapy techniques, including cell isolation, transduction, and expansion
• Hands-on experience with cell culture, aseptic technique, and cleanroom operations
• Familiar with the use and operation of equipment such as biological safety cabinets, balances, pipettes, etc.
• Identify and perform advanced troubleshooting and assist with technical issues
• Excellent professional documentation and verbal communication skills
• Ability to interact with other departments effectively; review work, communicate problems, suggest corrections, and enforce policy/procedures
• Ability to handle confidential company data and information
• Proficient with the Microsoft Office Suite
• Ability to work flexible hours and respond to unplanned manufacturing needs, including potential weekend or off-shift support
• Comfortable working in a cleanroom or controlled environment
• Strong interpersonal and leadership skills to lead, mentor, and motivate a team
• Ability to travel internationally (minimal)

Skills

• Leadership and team management
• Process transfer and technology transfer coordination
• Production planning and scheduling
• Quality systems and SOP development
• Safety and regulatory compliance
• Technical troubleshooting and problem-solving
• Documented communication and collaboration across departments

Education

• Master’s or Bachelor’s degree in a life sciences field (as specified in qualifications)

Additional Requirements

• Ability to travel internationally (minimal)