Job Description
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 ProductsSupport 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 staffPeople management responsibilities include, performance reviews, career development, coaching, compensation discussions and retentionSupport 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 practicesHolding regular staff 1 : 1 meetings to emphasize corporate culture, maintain morale, and provide a forum for staff development and collaborationCoordination with Manufacturing Leadership to determine and drive strategy developmentDriving the spirit of continuous improvementAccountable for working with internal teams to troubleshoot problems, suggest improvements, and identify & advocate for value-added projectsProvide front line support, including but not limited to support of training, scheduling, procedure writing and development, and troubleshooting and investigatory activitiesResponsible for understanding of budget profit / loss, and operation impactLiaison with support groups for day to day and mid-term needs - Supply Chain, Training, Quality Assurance, and Quality ControlSet team expectations and goals and assists in executing on the business direction for the teamIdentify and drive KPIs and assure that Manufacturing metrics are maintained and tracked as needed and assignedWork directly with Operators to identify areas requiring improvement, develop mitigation strategies, and drive execution of the sameAssist in production activities involving batches and APS runsEDUCATION 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). Continuous improvement mindset.Manager : Follows processes and policies in selection of methods and techniques (to obtain results) / Senior Manager : Implements processes and policies to selection of methods and techniques (to obtain results)Highly ethical and transparent, with professional sensitivity and care for confidentiality.Excellent written and verbal communication skillsStrong 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.
