Manager, Cell and Gene Therapy (GMP Lab)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, 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.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

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.

Discover Impactful Work:

Provides management and direction to staff and resources for project activities and needs, oversees daily operations to monitor quality and project timelines, and assists in preparation and implementation of company policies, quality systems and training programs. Ensures responsiveness to the customer and overall, client satisfaction. Plans and monitors the progress and quality of projects by utilizing the financial and quality management tools available. Ensures that staff develop to support department goals and business growth.

A Day in the Life:

• 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.

Keys to Success:

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

Knowledge, Skills, 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…