Manager, Cell and Gene Therapy (GMP Lab)

Thermo Fisher Scientific•Middleton, WI

9d•Onsite

About The Position

This fully onsite role is based at Thermo Fisher Scientific’s GMP Laboratory in Middleton, Wisconsin. The Manager, Cell and Gene Therapy provides management and direction to staff and resources for project activities, oversees daily operations to monitor quality and timelines, and helps prepare and implement company policies, quality systems, and training programs. The role supports responsiveness to customers and client satisfaction, plans and monitors project progress and quality using available financial and quality management tools, and develops staff to support department goals and business growth. The manager leads staff development and performance, allocates laboratory resources, coordinates work across internal functional and support groups, and monitors quality and productivity metrics. The role also works with clients on project scope, timelines, budgets, analytical and compliance matters, and potential business opportunities. It is accountable for adherence to GMP/GLP and other applicable laboratory or client requirements, and contributes to audits, SOP review and implementation, investigations, deviations, and quality-system improvements. Applicants may be located anywhere in the United States, but the role itself is fully onsite in Middleton, WI. Relocation assistance is provided. Candidates must be legally authorized to work in the United States and pass a comprehensive background check, including drug screening. The work takes place in a laboratory and office setting and may involve PPE, strong odors, potentially hazardous elements, and non-traditional work environments.

Requirements

Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
Comparable to 5–8 years of previous experience providing the knowledge, skills, and abilities to perform the job, or equivalent.
At least 2 years of management responsibility.
Ability to demonstrate behaviors aligned with Thermo Fisher’s 4i Values.
Ability to train and mentor junior staff.
Ability to cultivate a collaborative work environment within a team and across business areas.
Effective written, oral, and presentation skills.
Problem-solving and troubleshooting abilities.
Understanding of basic financial terms and definitions as applied to the business.
Ability to independently develop project proposals and plans.
Project and time management skills.
Ability to identify and implement common efficiencies across multiple programs or projects.
Understanding of the bid process and ability to use others’ expertise to develop programs for unique client needs.
Ability to cope with a dynamic work environment.
Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Ability to work upright and stationary and/or standing for typical working hours.
Ability to lift and move objects up to 25 pounds; the posting’s environmental conditions also state the ability to lift 40 pounds without assistance.
Ability to work in non-traditional work environments and use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Must be legally authorized to work in the United States and pass a comprehensive background check, including drug screening.

Responsibilities

Oversee daily staff activities, including interviewing, selection, professional development, goal setting, performance management, coaching, and mentoring.
Review and approve paid time off, leave, and overtime requests, and review timesheet reports for billing accuracy.
Allocate, schedule, and manage laboratory resources for project activities; update project status and revenue projections.
Communicate project performance metrics, quality updates, and staff development opportunities to employees.
Demonstrate process improvements and efficiency gains, and define and monitor quality and productivity metrics.
Coordinate and prioritize project activities with internal functional groups and support functions.
Identify opportunities within the client base and work with business development to pursue them.
Participate in project definition and client negotiations regarding timelines and budgets.
Participate in audits and general capabilities department tours.
Provide clients with recommendations on analytical and compliance issues.
Review and approve laboratory investigations, deviations, and QA facility and data audits.
Prepare and implement SOPs and company operational policies.
Ensure adherence to quality systems and recommend quality-system improvements.
Maintain the group’s knowledge and application of GMP/GLP and other laboratory or client requirements; participate in bi-annual SOP review and change, and own changes needed for SOP compliance.
Assist senior management in its responsibilities.