Group Leader, Biopharmaceuticals

Thermo Fisher Scientific•Middleton, WI

9d•Onsite

About The Position

Thermo Fisher Scientific is seeking a Group Leader for their Biopharmaceuticals department in Middleton, Wisconsin. This is a full-time, fully onsite role within a GMP Laboratory. The position requires legal authorization to work in the US without sponsorship and passing a background check including a drug screening. The role involves providing management and direction to laboratory staff and resources, overseeing daily operations to monitor quality and project timelines, and assisting in the preparation and implementation of company policies, quality systems, and training programs. The Group Leader will ensure responsiveness to customers and overall client satisfaction, while also planning and monitoring project progress and quality using available financial and quality management tools. The company's mission is to enable customers to make the world healthier, cleaner, and safer, and this role contributes to that mission through laboratory services that impact patient health.

Requirements

Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience.
1+ years of management responsibility.
Proven leadership skills.
Demonstrated experience with performance management and process improvement.
Ability to cultivate a collaborative work environment with a team.
Effective negotiating skills.
Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs.
Ability to troubleshoot multiple systems/methodologies.
Ability to independently optimize analytical methods.
Understanding of basic financial terms and definitions as it applies to the business.
Understanding of proposal and project scope as it relates to pricing, resource management and the impact on business.
Project and time management skills.
Effective written and oral communication skills as well as presentation skills.
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.

Nice To Haves

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Responsibilities

Provide management and direction to laboratory staff and resources for project activities and needs.
Oversee daily operations to monitor quality and project timelines.
Assist in preparation and implementation of company policies, quality systems and training programs.
Ensure responsiveness to the customer and overall, client satisfaction.
Plan and monitor the progress and quality of projects by utilizing the financial and quality management tools available.
Prepare, review, and approve study protocols, project status reports, final study reports and other project-related technical documents.
Design experimental study and participate in technical troubleshooting.
Review data for technical quality and compliance to protocols, methods and SOPs.
Review and approve laboratory investigations, deviations, and QA facility and data audits.
Lead client and FDA audits.
Allocate, schedule and manage laboratory resources for group's project activities and update project status.
Review timesheet reports for billing accuracy.
Respond to client's questions and needs; lead client technical meetings.
Assist in preparation of proposals by providing project definition.
Identify new opportunities within client base and ability to work with business development to pursue opportunities.
Coordinate and prioritize project activities with internal functional groups (physical testing, analytical development, microbiology, etc.) and support functions (QA, sample management, etc.).
Assist management in their responsibilities.
Prepare and implement PPD SOPs and company operational policies.
Ensure adherence and make recommendations to quality system improvements.
Train and mentor junior staff.