Manager, Cell and Gene Therapy (GMP)

Manager

Department: Cell and Gene Therapy

Location: Middleton, Wisconsin

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance will be provided for this position. Must be legally authorized to work in the United States. Must be able to pass a comprehensive background check, which includes a drug screening.

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.

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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
• 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 it applies 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 can utilize expertise of others to develop programs to meet unique client needs
• Proven ability to cope with a dynamic work environment

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.