Senior Manager, GMP Laboratory Operations

Thermo Fisher Scientific • Indianapolis, IN

21h • Onsite

About The Position

This is a fully onsite role based at our GMP Laboratory in Greenfield, IN. We welcome applicants from all locations within the U.S. Must be legally authorized to work in the United States without sponsorship. 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. In this role you would lead a segment of the Biopharmaceutical laboratory, overseeing group leaders and their teams to ensure high-quality, on-time delivery of analytical services. The Senior Manager is responsible for driving operational performance, building a high-trust team environment, and implementing process improvements to scale the business. In addition to lab operations, this role owns resource planning, financial tracking, and client delivery, partnering cross-functionally to support growth and continuous improvement initiatives.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience.
• 5+ years of management responsibility
• Proven leadership skills
• Full understanding of GxP regulatory environments (FDA, ICH) and ability to operate effectively within a regulated laboratory setting
• Experience managing operations, resources, and team performance
• Demonstrated coaching and mentoring skills
• Strong communication and cross-functional collaboration skills
• Project and time management skills
• Ability to implement quality systems and process improvements
• Ability to provide guidance to clients on analytical issues and regulatory requirements
• Knowledge of budgeting, forecasting and fiscal management
• Demonstrated strategic planning skills
• Strong organizational agility and demonstrated drive for results.

Nice To Haves

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Responsibilities

• Partner with clients and business development to shape project scope, develop proposals, and drive successful outcomes, including ownership of pricing strategy, timelines, and contract negotiations.
• Lead and develop group leaders and their teams, setting priorities, optimizing resource allocation, and ensuring alignment to operational and business goals.
• Ensure high-quality, compliant data delivery by overseeing technical review processes, leading investigations and deviations, and acting as a key leader during client and regulatory audits.
• Own and manage financial performance, including revenue forecasting, resource utilization, and project profitability to drive informed business decisions.
• Provide oversight of study execution and technical documentation, ensuring alignment with client expectations, regulatory standards, and operational timelines.
• Contribute to business growth and market presence by supporting technical sales efforts, developing materials, and representing the organization at industry conferences.
• Partner with senior leadership to drive strategic initiatives, including capacity planning, capability expansion, and long-term business growth.
• Lead the development and evolution of operational processes and quality systems, driving continuous improvement while ensuring compliance in a regulated environment.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior