Scientist - Analytical Development

Work Your Magic with us! Start your next chapter and join Millipore Sigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

At Millipore Sigma, as a Scientist 1 - Analytical Development, you will be the primary scientific lead for assigned studies within the Analytical Laboratory as part of the Analytical & Bioassay department. This role is responsible for leading analytical method development/validation and feasibility/transfer to support the manufacture of clinical and commercial products. The Scientist will collaborate with cross-functional teams to ensure analytical methods are robust, reliable, standardized, and ready for implementation.

• Understand GMP requirements for analytical method validation, transfer and associated documentation.
• Act as a subject matter expert (SME) for analytical methods and provide technical guidance to analysts, study managers, and cross-functional teams.
• Apply laboratory techniques and scientific expertise to design and execute experiments that address complex analytical challenges.
• Design, optimize, and troubleshoot analytical methods for a wide range of modalities, including monoclonal antibodies (mAbs), cell and gene therapy products, antibody-drug conjugates (ADCs), mRNA therapeutics, viral vectors, and other biotherapeutics, ensuring methods are fit-for-purpose and aligned with phase-appropriate regulatory expectations.
• Lead analytical method development/validation and feasibility/transfer activities, ensuring studies are initiated and completed on schedule.
• Prepare, review, and approve protocols, reports, SOPs, laboratory records, technical specifications, and other related documents.
• Execute analytical methods in the lab to support method development/validation and feasibility/transfer.
• Perform analytical testing in accordance with SOPs and cGMP regulations.
• Transfer GMP assays to routine team and provide training to analysts, study managers, report writers, and QA.
• Operate and maintain lab equipment as required by SOPs and testing procedures.
• Utilize applicable computer programs during testing and routine tasks (i.e. Word, Excel, Oracle, LIMS, BRIQS, etc.).
• Lead general change control and resolve deviations by completing event records.
• Contribute ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipment.
• Ensure current regulatory requirements and technical needs of internal and external clients are appropriately met.
• Maintain strong communication skills to effectively interact with internal and external stakeholders.
• Participate in client interactions, scientific discussions, and technical presentations as a representative of the Analytical Development team.
• Perform other duties and responsibilities as assigned.

• Ph.D. in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.)

-OR-

• Master’s Degree in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.), with 3+ years relevant experience

-OR-

• Bachelor’s Degree in a scientific discipline (e.g., Analytical Chemistry, Chemistry, Biology, etc.), with 5+ years industry experience

• Broad working knowledge…