Please note this role is based onsite in Middleton, Wisconsin

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!

Discover Impactful Work:

Responsible for the regulatory and scientific conduct of development, validation, and stability projects. Evaluates client comments on data for trends, identify trends and communicate to leaders and cross functional teams for improvement areas.  Supports troubleshooting on multiple analytical instrumentation (HPLC, UPLC, Densitometers, UV spectrophotometers) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client. Routinely acts as the technical project leader for multiple projects, interacts with clients on a weekly basis (or as needed) to provide updates, reviews and evaluates data, writes reports and protocols.  Evaluates client comments on data for trends, identify trends and communicate to leaders and cross functional teams for improvement areas. 

A day in the Life:

• Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
• Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
• Communicates data and technical issues to clients on a weekly basis (or as needed).
• Provides technical guidance and training to staff.
• Leads analytical (procedural and instrumental) troubleshooting sessions.
• Assists in preparation and implementation of SOPs and quality systems.
• 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.
• Able to gather client comments on data, trend comments and identify opportunity areas and effectively communicate updates to clients routinely.
• Manage timeframes for client feedback to be addressed. 
• Implement solutions to address client needs around appropriate documentation.
• Managing life cycle of client data over a period of time.

Qualifications - External

Keys to Success:
Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years).
• 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.
• Familiarity with effective GMP documentation practices.

Knowledge, Skills, Abilities

• Knowledge of general chemistry and separation science
• Ability to independently perform root cause analysis for method investigations
• Proficiency on technical operating systems
• Proven problem solving and troubleshooting abilities
• Proven ability in technical writing skills
• Time management and project management skills
• Good written and oral communication skills, internal and external customers.
• Ability to work in a collaborative work environment with a team
• Ability to train junior staff

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.