Senior Manager, GMP Laboratory Operations

Work Schedule

Environmental Conditions

Job Description

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 youll 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.

Role Overview

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.

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.

Qualifications

• Bachelors 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

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.

Knowledge Skills Abilities:

• 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.

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.

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 100000 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.

Apply today to help us deliver tomorrows breakthrough.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

Accessibility/Disability Access

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*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other non-disability related technical issues will not receive a response.