Sr. Manager, Cell and Gene Therapy

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 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