Senior Research Scientist (HPLC, CE, GMP) Full-time

Senior Research Scientist

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. 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.

Discover impactful work:

As a Senior Research Scientist you will coordinate sophisticated analytical development and specialty technologies projects to build new analytical methods, improve existing methods, and transfer client-provided methods using multiple instruments and detection techniques. You will provide technical and regulatory consultation to internal groups and clients about their programs and provide technical guidance and mentorship to senior staff members in performing laboratory activities. Additionally, you will routinely act as the technical project leader for multiple projects, interact with clients to provide technical project updates, review and evaluate data, and write reports and protocols.

Key responsibilities:

• Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
• Acts as on-site Subject Matter Expert (SME) for instrumentation / technique / technology.
• Evaluates available technical options to acquire desired quality of analytical results, economics, ease of introduction into a production environment, and adaptability in analytical applications.
• Demonstrates viability of in-house developed methods and methods transferred from clients by crafting appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
• Lead client discussions regarding project definitions, technical information exchanges and discussions of project status. Provides recommendations to clients on technical and regulatory issues.
• Reviews protocols, project status reports, final study reports and other project related technical documents.
• Assists business development group in technical sales and marketing, and in preparation of technical marketing materials, and presents posters and makes podium presentations at conferences.
• Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Keys to success:

Education and experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ 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.

Knowledge, skills and abilities:

• Demonstrated experience with method development and validation for HPLC, CE, and ADCs preferred
• Knowledge of feasibility plans, Empower Software, and GMP (Good Manufacturing Practice) regulations preferred
• Effective written and oral communication skills as well as presentation skills
• Knowledge and application of industry best practices not yet represented by global regulatory requirements
• Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
• Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA mentorship
• Ability to independently review and understand project proposals/plans
• Proven track record in technical writing skills
• Ability to work in a collaborative work environment with a team
• Proven problem solving and troubleshooting abilities
• Ability to independently optimize analytical methods
• Time management and project management skills

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.