Group Leader - Cell and Gene Therapy, GMP

Thermo Fisher Scientific•Middleton, WI

3d•Onsite

About The Position

Provides line-level management coordination of resources and work schedules for laboratory activities. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed. Ensures that laboratory staff continues to be developed to keep pace with department goals and growth. Performs lab work in accordance with client protocols, methods and requirements. Prepares study protocols, project status reports, final study reports and other project-related technical documentation. Designs experimental study and participates in technical troubleshooting. Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviation. Organizes, schedules and supervises laboratory resources for group's project activities and updates project status. Responds to client questions and needs, coordinates client communication and records meeting minutes. Assists group leaders in their responsibilities. Assists in preparation and implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies.

Requirements

Bachelors degree or equivalent
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience.
1+ year of leadership responsibility
Demonstrated proficiency on technical operating systems
Proven leadership skills
Ability to train and mentor junior staff
Demonstrated ability to be project solution driven
Good written and oral communication skills as well as presentation skills
Can independently perform root cause analysis for method investigations
Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
Ability to independently optimize analytical methods
Project and time leadership skills
Must be legally authorized to work in the United States.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

Prior GMP experience preferred

Responsibilities

Provides line-level management coordination of resources and work schedules for laboratory activities.
Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs.
Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed.
Ensures that laboratory staff continues to be developed to keep pace with department goals and growth.
Performs lab work in accordance with client protocols, methods and requirements.
Prepares study protocols, project status reports, final study reports and other project-related technical documentation.
Designs experimental study and participates in technical troubleshooting.
Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs.
Reviews laboratory investigations and deviation.
Organizes, schedules and supervises laboratory resources for group's project activities and updates project status.
Responds to client questions and needs, coordinates client communication and records meeting minutes.
Assists group leaders in their responsibilities.
Assists in preparation and implementation of PPD/client SOPs and company operational policies.
Ensures adherence to SOPs, safety standards and company policies.