Manager, Manufacturing Operations

You will be responsible for understanding Cellectis' GMP manufacturing schedule/timeline, anticipate related needs and constraints, and help drive strategy accordingly, forecasting out at least 6 months. This role will also lead individual and team development to ensure a prepared and empowered workforce that can execute processes on time while continuously improving in quality and efficiency.

Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Cellectis’ Values & Guidelines

POSITION RESPONSIBILITIES

• Provide leadership to support the Manufacturing Operations team in:
  • Meeting process demands through planning, scheduling, manufacturing, and delivery of clinical and future commercial cell therapy products according to established procedures, regulations and Quality expectations
  • Forecasting out at least 6 months to ensure short and mid-term staffing and availability of resources (room/equipment/staff) to perform the manufacture of Cell Therapy Products
  • Support and development of the ‘On the Job’ training program and resources for new Operators onboarding and proficiency training as well as training and development of existing staff
  • People management responsibilities include, performance reviews, career development, coaching, compensation discussions and retention
  • Support technical transfer activities from process development and MSAT to Manufacturing (i.e. documentation and batch record development)
  • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices
  • Holding regular staff 1:1 meetings to emphasize corporate culture, maintain morale, and provide a forum for staff development and collaboration
  • Coordination with Manufacturing Leadership to determine and drive strategy development
  • Driving the spirit of continuous improvement
• Accountable for working with internal teams to troubleshoot problems, suggest improvements, and identify & advocate for value-added projects
• Provide front line support, including but not limited to support of training, scheduling, procedure writing and development, and troubleshooting and investigatory activities
• Responsible for understanding of budget profit/loss, and operation impact
• Liaison with support groups for day to day and mid-term needs – Supply Chain, Training, Quality Assurance, and Quality Control
• Set team expectations and goals and assists in executing on the business direction for the team
• Identify and drive KPIs and assure that Manufacturing metrics are maintained and tracked as needed and assigned
• Work directly with Operators to identify areas requiring improvement, develop mitigation strategies, and drive execution of the same
• Assist in production activities involving batches and APS runs

EDUCATION AND EXPERIENCE

• Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering or relevant).
• Minimum 5-7 years of cGMP environment, involving aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience (deep understanding of cGMP and cGLP) and leadership experience or equivalent combination of experience required.
• 2 years of previous people management experience, preferred.
• A proven leader with demonstrated management skills in providing direction, coaching and performance management to an aseptic manufacturing team.
• Experience with using manufacturing equipment: centrifuges, incubators, and other common laboratory/cleanroom equipment.
• Demonstrated ability to design, execute and analyze manufacturing documents, investigate and propose approaches to technical and regulatory issues.

Technical Skills Requirements / Core Competencies

• Experience with cellular or tissue therapies; autologous or allogenic, is preferred.
• Ability to think tactically and strategically (detail-oriented). Continuous improvement mindset.
• Highly ethical and transparent, with professional sensitivity and care for confidentiality.
• Excellent written and verbal communication skills
• Strong collaborative, presentation, and influencing skills; and ability to work well in a cross-functional, matrix environment.
• Proficiency in MS Office (Word, Microsoft Excel, and Power Point) required.

PHYSICAL POSITION REQUIREMENTS
Requires the ability to sit or stand at a computer or workstation for long stretches of time; typing, operating lab/manufacturing equipment. Frequently operates a computer, office productivity machinery, operate lab/manufacturing equipment. The person in this position needs to occasionally move about inside the office / lab-manufacturing environment to access file cabinets and office/lab equipment. May occasionally lift objects up to five pounds. Communicates with others on a daily basis to exchange information.