Sr. Manager, Cell and Gene Therapy

JOB DESCRIPTION

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.), Standing for full shift

Job Description

Senior Manager

Department: Cell and Gene Therapy

Location: Middleton, Wisconsin

Details: Full time, fully onsite

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.

The Role

The Senior Manager supervises and assists line leaders and high-level individual contributors with tasks such as resource management, technical and compliance related issues. Additionally, the Senior Manager plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. 

Essential Functions

• Interacts with clients, business managers and business development on requests for proposals and project definition. Prepares, reviews and approves bids and proposals, scope of work and pricing. 

• Manages work responsibilities of line leaders as well as prioritizes 
  communications and resources. Provides mentorship, guidance and development to team members.

• Reviews and approves laboratory investigation, deviations, and QA facility and data audits. Leads client and regulatory audits.

• Prepares and updates revenue projection reports, ensures accurate revenue recognition and billing, provides 3-6 month capacity plans for department, and drives project profitability.

• Prepares and implements SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements

• Procures and allocates analytical instrumentation, Information Technology, space and other resources to appropriate areas based on business need.

• Supports laboratory department in method/instrumentation troubleshooting, laboratory investigations and internal/external conflict resolution.

Key Qualifications

Education and Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience.

• 5+ years of management responsibility

• Proven leadership skills

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

• Thorough knowledge of GMP, GCP or GLP

• In-depth knowledge of clinical laboratory science, ICH guidelines, FDA regulations concerning clinical labs processes in drug development process, method development, method validation, R&D, sample production and/or data processing

• Strong leadership skills including project level budgeting, forecasting and fiscal management

• Project and time management skills

• Excellent communication/interpersonal skills including presentation skills

• Developing strategic planning skills

• In-depth global and cultural awareness

• Strong organizational agility and demonstrated drive for results

• Excellent coaching and mentoring skills

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.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

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