Manager, Cell and Gene Therapy (GMP Lab)

About the Role

This is a fully onsite position based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US; relocation assistance will be provided. The role provides management and direction to staff and resources for project activities, oversees daily operations to monitor quality and project timelines, and assists in preparation and implementation of company policies, quality systems, and training programs. The position ensures responsiveness to the customer and overall client satisfaction, plans and monitors project progress and quality using financial and quality management tools, and ensures staff development to support department goals and business growth.

Responsibilities

• Oversee daily activities of staff, including interviewing, selection, professional development, goal setting, performance management, coaching, and mentoring
• Review and approve requests for paid time off, leave, overtime, and review timesheet reports for billing accuracy
• Allocate, schedule, and manage laboratory resources for group project activities; update project status and revenue projections
• Regularly communicate project performance metrics, quality updates, and opportunities for staff development
• Demonstrate process improvements and efficiency gains to meet department goals
• Define and monitor performance metrics for quality and productivity
• Coordinate and prioritize project activities with internal functional groups (physical testing, microbiology, etc.) and support functions (QA, sample management, etc.)
• Identify new opportunities within client base and work with business development to pursue opportunities
• Participate in project definition and negotiations with clients on timelines and budget
• Participate in audits and general capabilities department tours
• Provide recommendations to clients 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 and make recommendations to quality system improvements
• Maintain accountability for group's knowledge and application of good practices pertaining to GMP/GLP and/or other laboratory/client requirements
• Participate in bi-annual SOP review and change; own changes needed to comply with SOPs
• Assist Senior Management in their responsibilities

Qualifications

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 5–8 years) or equivalent
• 2+ years of management responsibility
• Must be legally authorized to work in the United States
• Must be able to pass a comprehensive background check, including a drug screening

Skills

• Demonstrate behaviors aligned to the 4i Values of Thermo Fisher (Integrity, Intensity, Innovation, Involvement)
• Ability to train and mentor junior staff
• Ability to cultivate a collaborative work environment with a team and across business areas
• Effective written and oral communication skills as well as presentation skills
• Proven problem-solving and troubleshooting abilities
• Understanding of basic financial terms and definitions as they apply to the business
• Ability to independently develop project proposals/plans
• Project and time management skills
• Proven ability to identify and implement common efficiencies across multiple programs/projects
• Demonstrated understanding of the bid process and ability to utilize expertise of others to develop programs to meet unique client needs
• Proven ability to cope with a dynamic work environment

Work Environment & Physical Requirements

• Able to lift 40 lbs. without assistance
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards
• Laboratory setting with some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)
• Exposure to strong odors (chemical, lubricants, biological products, etc.)
• 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

Schedule

Standard (Mon–Fri)

Location

Fully onsite at GMP Laboratory, Middleton, WI. Relocation assistance provided.