**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.) **Job Description** **Analytical Services Division, GMP Laboratories, Middleton, WI** 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. **How will you make an impact?** Oversees the technical management, mentoring, and customer scientific interface for the CDMO (Contract Development & Manufacturing Organization) sector within the GMP business. From evaluation of new client request to execution/onboarding of new methods that meet client needs, regulatory requirements, and yields profitable results for the business. Collaborates closely with Lab Operations leaders, project management, and laboratory personnel within a matrix environment. **What will you do?** + Provides technical leadership to laboratory staff and customer. Leverages the integration of operational processes, research & development and quality assurance functions for optimal performance within the labs. + Supports Business Development in maintaining relationships by delivering value via quality, accuracy, and speed of delivery. + Oversees method onboarding activities in the laboratory to ensure compliance with company SOPs, policies and client timelines and deliverables. + Collaborates with operations leaders to identify and schedule project work for technical mentees in a matrix environment + Interacts extensively with operations leaders/support management/technical staff to ensure client deliverables and needs are met. + Partners with Operations Leadership team to determine business need for analytical instrumentation, Information Technology, space and other resources to appropriate areas + Supports laboratory department in method/instrumentation troubleshooting, laboratory investigations and internal/external conflict resolution. + Assists in designing method validation or method transfer protocols and establish project timelines. + Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. **How will you get here?** Bachelor’s degree in chemistry or other scientific discipline required 12+ years of relevant experience in a pharmaceutical or analytical testing laboratory that provides the knowledge, skills, and abilities to perform the job, including 5+ years of leadership responsibility Technical mentorship and leadership skills **Knowledge, Skills, Abilities** + Proficient in Microsoft Excel and Word + Proven track record to interpret data by performing trend analysis + Proven track record in technical writing skills + Ability to independently optimize analytical methods + Problem solving and troubleshooting abilities + Good written and oral communication skills + Time management and project management skills + Ability to work in a collaborative work environment with a team + Skilled at written and verbal communication, documenting and sharing experimental methods, data, outcomes, and conclusions to diverse audiences. + Ability to identify issues and adapt experiments on-the-fly, a skill facilitated by strong attention to detail and a willingness to ask for help. + Skilled at prioritization and navigating ambiguity with a positive demeanor. **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!** **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. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. 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.