Senior Manager, Biopharmaceuticals (GMP Laboratory)

Thermo Fisher Scientific•Middleton, WI

2d•Onsite

About The Position

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 is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. 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. A Day in the Life The Senior Manager supervises and assists group leaders, scientists, and medical technologists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. This role plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. Additionally, the Senior Manager assists the division director in strategic planning, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.

Requirements

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
Full understanding of laboratory requirements, PPD and client SOPs, ICH guidelines, USP requirements and FDA guidance
Proven technical troubleshooting analytical instrumentation and problem solving abilities
Excellent written and oral communication skills
Project and time management skills
Ability to implement quality systems and process improvements
Ability to provide guidance to clients on analytical issues and regulatory requirements
Knowledge of budgeting, forecasting and fiscal management
Demonstrated coaching and mentoring skills
Demonstrated strategic planning skills
Strong organizational agility and demonstrated drive for results.

Responsibilities

Interact with clients and business development on requests for proposals and project definition.
Prepare, review and approve bids and proposals, scope of work and pricing.
Negotiate with clients on timelines and pricing.
Manage/direct work responsibilities of group leaders as well as prioritize talks and resources.
Review data for technical quality and compliance to protocols, methods and SOPs.
Review and approves laboratory investigation, deviations, and QA facility and data audits.
Lead client and regulatory audits.
Prepare and update revenue projection reports, review Partner and timesheet reports for revenue recognition and billing, evaluate resource utilization reports and project profitability.
Review and approve study protocols, project status reports, final study reports and other project related technical documentation.
Assist in technical sales and marketing, prepare technical marketing materials, and participate in poster and podium presentations in technical conferences.
Assist upper management in strategic planning, budgeting, new capabilities development and other responsibilities.
Prepare and implement SOPs and company operational policies.
Ensure adherence and makes recommendations to quality system improvements.