Group Leader - Cell and Gene Therapy, GMP

Job Description

Group Leader - Cell and Gene Therapy

Monday - Friday, 1st shift

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance will be provided for this position.

Must be legally authorized to work in the United States.

Must be able to pass a comprehensive background check, which includes a drug screening.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work: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.A day in the Life:

• 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.

Keys to Success:Education and Experience: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

Knowledge, Skills, Abilities

• 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
• Prior GMP experience preferred

Work Environment:Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.