Job Description

　　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 guides. As the world leader in serving science, our laboratory professionals bring their dedication to accuracy and quality to deliver groundbreaking innovations.

　　Department: Extractable and LeachableLocation: Middleton, WI - Lab BasedNotes: Full-time, Benefits, Annual Bonus, 401k Match, PTO, Relocation Assistance Available

　　Discover Impactful Work:

　　Supervises and assists group leaders, scientists, and medical technologists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. Plans, advises and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. Assists the division director in planning, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.

　　A day in the Life:

　　Interacts with clients and business development on requests for proposals and project definition. Prepares, reviews and approves bids and proposals, scope of work and pricing. Negotiates with clients on timelines and pricing.Leads/advises work responsibilities of group leaders as well as prioritize talks and resources.Reviews data for technical quality and compliance to protocols, methods and SOPs. Reviews and approves laboratory investigation, deviations, and QA facility and data audits. Leads client and regulatory audits.Prepares and updates revenue projection reports, reviews Partner and timesheet reports for revenue recognition and billing, evaluates resource utilization reports and project profitability.Reviews and approves study protocols, project status reports, final study reports and other project related technical documentation.Assists in technical sales and marketing, prepares technical marketing materials, and participates in poster and podium presentations in technical conferences.Assists upper management in strategic planning, budgeting, new capabilities development and other responsibilities.Prepares and implements PPD clinical research services SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvement

　　Keys to Success:

　　Education and Experience:

　　Bachelors degree plus previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years, PhD preferred) or equivalent and relevant combination of education, training, & experience5+ years of management responsibilityValidated leadership skills

　　Knowledge, Skills and Abilities:

　　Previous industry laboratory experience requiredPrevious experience with drug substance and drug substance analytical testingIndependent method development and validation experienceStability program management experience preferredGMP experienceFull understanding of laboratory requirements, PPD clinical research services and SOPs, ICH guidelines, USP requirements and FDA guidanceProven technical troubleshooting analytical instrumentation and problem solving abilitiesExcellent written and oral communication skillsProject and time management skillsAbility to implement quality systems and process improvementsAbility to provide guidance to clients on analytical issues and regulatory requirementsKnowledge of budgeting, forecasting and fiscal managementValidated coaching and mentoring skillsDemonstrated strategic planning skillsStrong organizational agility and demonstrated drive for results

　　Working Environment:

　　PPD clinical research services 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 poundsAble 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 optimally 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! http://jobs.thermofisher.com

　　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

　　Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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