Senior Manager / Manager, Manufacturing Operations

POSITION SUMMARY
In this role you will support multiple shift-based teams of Manufacturing and Technician Operators. This positions partners with the Lead Operator as well as supporting functional areas within the business to deliver on day to day management, processing, cleaning and sanitization, and quality needs. You will be accountable for the supervision and management of Associates, as well as the resources and time required to support the execution manufacturing projects at the site.

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

Determination of Manager / Senior Manager title will be determined based on experience, core competencies and business needs.

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).
• Manager: Minimum 5 years / Senior Manager: Minimum 8 years of experience within a 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.
• Manager: 1 year / Senior Manager: 2+ years of previous direct 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). Co