Supervisor, Cell and Gene Therapy

Thermo Fisher Scientific•Middleton, WI

5d•Onsite

About The Position

Supervisor - 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. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

Bachelors degree or equivalent
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.
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

Nice To Haves

Prior experience with PCR, Sanger Sequencing, and Next Gen Sequencing preferred
Prior GMP experience preferred

Responsibilities

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.