Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Manager

Department: Biopharmaceuticals

Location: Middleton, Wisconsin

Join us as an experienced Manager in our Laboratory Services Team!

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.

The Role

The Manager provides management and direction to staff and resources for project activities and business needs, oversees daily operations to monitor quality and project timelines, and assists with the preparation and implementation of company policies, quality systems, and training programs. Additionally, the Manager ensures responsiveness to customers and overall client satisfaction, plans and monitors the progress and quality of projects by utilizing the financial and quality management tools available, and ensures that staff develop to support department goals and business growth.

Essential Functions

• Oversees the daily activities of staff, including interviewing, selection, professional development, goal setting, performance management, coaching and mentoring.

• Reviews and approves requests for paid time off, leave, overtime, and reviews timesheet reports for billing accuracy.

• Allocates, schedules and manages laboratory resources for group's project activities and updates project status and revenue projections.

• Regularly communicates to staff project performance metrics, quality updates and opportunities for staff development.

• Responsible for demonstrating process improvements and efficiency gains to meet department goals. Defines and monitors performance metrics for quality and productivity.

• Coordinates and prioritizes project activities with internal functional groups (physical testing, microbiology, etc.) and support functions (QA, sample management, etc.).

• Identifies new opportunities within client base and ability to work with business development to pursue opportunities.

• Participates in project definition and negotiations with client on timelines and budget.

• Participates in audits and general capabilities department tours.

• Provides recommendations to clients on analytical and compliance issues.

• Reviews and approves laboratory investigations, deviations, and QA facility and data audits.

• Prepares and implements SOPs and company operational policies.

• Ensures adherence and makes recommendations to quality system improvements.

• Accountable for group's knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements.

• Participates in bi-annual SOP review & change. Ownership of changes needed to comply with SOPs.

• Assists Sr Management in their responsibilities.

Key Qualifications

Education and Experience:

• 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 5-8 years) or equivalent.

• 2+ years of management responsibility

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 and Abilities:

• To demonstrate behaviors which align to the 4i Values of Thermo Fisher

• Ability to train and mentor junior staff

• <