Principal Scientist

Element is currently hiring for a Principal Scientist to join our growing team in Ann Arbor, MI.

Lead the development, validation, and transfer of advanced analytical methods for the quantification of Nitrosamine impurities and other contaminants (small molecules, NDSRIs) in drug products, including extractable and leachable (E&L) substances.
• Design and oversee complex experiments to identify and address the root causes of Nitrosamine impurity formation, ensuring scientifically rigorous methodologies are applied.
• Drive chemical extraction studies on container closure systems and drug products, focusing on E&L testing, while ensuring data integrity and accuracy.
• Apply advanced mass spectrometry techniques (LC-MS/MS, GC-MS/MS) to solve high-impact analytical challenges, and develop novel approaches for identifying and quantifying impurities.
• Take ownership of cross-disciplinary project management, leading teams to meet project goals, timelines, and regulatory requirements. Provide strategic guidance to ensure successful project delivery.
• Stay at the forefront of industry regulations and emerging trends, ensuring research, data collection, and reporting comply with global regulatory requirements.
• Provide expert insights and leadership in GxP regulations, playing a key role in ensuring the efficiency and compliance of the product registration process.
• Innovate and optimize analytical methodologies to meet both customer and project requirements, with an emphasis on ensuring robust E&L testing capabilities.
• Lead the generation of scientific reports and documentation, maintaining the highest standards in compliance with cGMP and regulatory requirements.
• Analyze complex data sets using both qualitative and statistical methods, deriving actionable insights and supporting conclusions with strong evidence.
• Exhibit exceptional problem-solving, troubleshooting, and analytical skills, guiding teams through challenges and continuously improving workflows.
• Champion safety protocols, leading by example in promoting laboratory safety practices, including the use of appropriate personal protective equipment (PPE).
• Oversee and maintain comprehensive laboratory documentation to ensure proper tracking and compliance with regulatory standards.
• Ensure adherence to relevant government regulations (FDA, cGMP, DEA, ICH, etc.), providing leadership in regulatory inspections and audits.
• Mentor and train junior scientists, providing technical leadership and fostering their professional growth.
• Perform other duties as assigned, bringing expertise and leadership to a range of scientific challenges.
• Collaborate with Business Development (BDs), Project Managers (PMs), and other stakeholders to ensure the timely delivery of projects to clients.

• Ph.D. in Chemistry or a related field with extensive industrial experience; additional relevant experience in a leadership role is highly desirable.
• Proven expertise in a cGMP-compliant laboratory setting, with a strong background in method development, validation, and transfer.
• Extensive experience using advanced analytical techniques such as LC-MS/MS, GC-MS/MS for small molecule analysis, including Nitrosamines, E&L substances, and other impurities in both small and large molecule drug products.
• Expert-level proficiency in interpreting complex scientific data and drawing clear, actionable conclusions.
• Highly skilled in scientific writing, including preparing detailed regulatory documents, reports, and manuscripts for publication or internal use.
• Strong history of delivering impactful scientific presentations to both technical and non-technical stakeholders, including regulatory bodies and cross-functional teams.
• Exceptional project management skills, with a proven ability to lead cross-functional teams, prioritize tasks, and meet tight deadlines.
• Demonstrated leadership qualities, including the ability to guide, mentor, and develop teams of scientists in both technical and professional aspects.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams and functions.
• Advanced problem-solving abilities, with a track record of delivering innovative solutions to complex scientific challenges.
• Ability to thrive in a fast-paced, high-pressure environment, while maintaining a focus on quality and compliance.
• Proficiency in Microsoft Office Suite, laboratory management software, and other analytical tools.
• A comprehensive understanding of the relevant regulatory frameworks (FDA, cGMP, ICH, DEA, etc.) and the ability to navigate these regulations effectively.

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Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner".

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.