Senior Manager, GMP Laboratory Operations
ThermoFisher Scientific, Indianapolis, IN, United States
Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
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.
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
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
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 skillsAbility 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
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*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.
Equal Employment Opportunity
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.
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First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
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.
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
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
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 skillsAbility 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
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*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.
Equal Employment Opportunity
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.
#J-18808-Ljbffr