Lead, Cell Therapy Manufacturing Operations

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

EDUCATION:

• Minimum required education: High School Diploma/ GED.
• Higher education (College degree) preferred.

EXPERIENCE:

• 3 years of cGMP experience in cell therapy required.
• Experience in Aseptic cell culture processing in ISO 5 biosafety cabinets handling human derived materials.
• Experience with cell therapy automation technologies including cell separation technologies for autologous/allogenic product manipulation.
• Experience in leadership.

KNOWLEDGE, SKILL AND ABILITIES:

• High level of technical skills and the ability to train/mentor others.
• Attention to detail and a systematic approach to investigations.
• Hands on approach and flexible attitude to daily work/responsibilities, ability to lead by example.
• Effective in technical and organizational troubleshooting to root cause.
• Ability to communicate effectively within and between teams and is effective in giving and receiving/acting upon feedback.
• The ideal candidate for this position will need to be self-starting, focused on developing their personal and technical skills.

• Assist supervisor and manager to create objectives for Manufacturing group.
• Take accountability for results and responsibility for the decisions made during the shift.
• Support investigation and close out any deviations and CAPAs assigned to dept.
• Set daily direction for your departments by optimally leading or assisting tiered meetings and daily operations. This will include, but is not limited to:
• Reviewing daily results to establish gaps and priorities.
• Lead troubleshooting of open barriers to the root-cause.
• Support the Team in resolution of barriers.
• Contribute to process gap assessment and creation of control strategy.
• Person-in-plant coverage and first-line technical support during day-to-day operations.
• Review and learn from daily activities to calibrate and develop the Team members.
• Ensure effective communication and relay collaboration within and between shifts.
• Most importantly, you must empower the individuals within the department, and develop them into a strong, autonomous and engaged team:
• Ensure training requirements for individual roles are appropriate and comprehensive of all job-related tasks.
• Author or collaborate to write and review batch records, protocols, and reports with minimum supervision.
• Ensure all mandatory training requirements are completed as required.
• Partner with supervisors and other leads to map out training plans for individual employees.
• Coordinate implementation of document updates, ensuring operator awareness and plan training where required.
• Build an environment that encourages individual and team growth.
• Set clear, comprehensive expectations, provide meaningful, timely feedback about performance.
• Train and mentor to continuously improve individual performance and business results.
• Learn by doing and teach by example and promote ‘Review and learn’ approach at individual, team and department levels.
• In the above effort, focus on mentoring, calibration and development of any operators.