Manager, Cell and Gene Therapy (GMP)

About 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, and ensures staff development to support department goals and business growth.

Responsibilities

• Oversees daily activities of staff, including hiring, professional development, goal setting, performance management, coaching, and mentoring.
• Reviews and approves requests for paid time off, leave, overtime, and timesheet reports for billing accuracy.
• Allocates, schedules, and manages laboratory resources for project activities and updates project status and revenue projections.
• Communicates project performance metrics, quality updates, and staff development opportunities.
• Drives 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 and support functions.
• Identifies new opportunities within the client base and collaborates with business development.
• Participates in project definition, negotiations, and client interactions.
• Participates in audits and department tours.
• Provides recommendations to clients on analytical and compliance issues.
• Reviews and approves laboratory investigations, deviations, and QA audits.
• Prepares and implements SOPs and company operational policies.
• Ensures adherence to quality systems and recommends improvements.
• Maintains group's knowledge and application of GMP/GLP and other laboratory requirements.
• Participates in bi-annual SOP review and change management.
• Assists Senior Management in their responsibilities.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• 5-8 years of relevant experience, including 2+ years of management responsibility.
• Equivalent combinations of education, training, and experience may be considered.

Skills

• Ability to train and mentor junior staff.
• Cultivates a collaborative work environment.
• Effective written, oral, and presentation skills.
• Proven problem-solving and troubleshooting abilities.
• Understanding of basic financial terms and their application to the business.
• Project and time management skills.
• Ability to develop project proposals and plans independently.
• Understanding of the bid process and ability to develop programs for unique client needs.
• Ability to thrive in a dynamic work environment.

Work Environment

• Adherence to Good Manufacturing Practices (GMP) and safety standards.
• Laboratory and office setting with some PPE requirements (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Fully onsite role at the GMP Laboratory in Middleton, WI.
• Relocation assistance provided.
• Must be legally authorized to work in the United States and pass a comprehensive background check, including drug screening.
• Ability to communicate effectively with diverse groups.
• Able to work stationary or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• May have exposure to potentially hazardous elements in a laboratory environment.
• Able to perform under pressure while managing multiple projects.

Location: Middleton, Wisconsin
Work Schedule: Standard (Mon-Fri)