Scientist 1 - Analytical Development

About the role

Your Role At MilliporeSigma, 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.

Responsibilities

• 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.

Requirements

Minimum Qualifications: 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

Qualifications

Preferred Qualifications: Broad working knowledge of the field, with experience in relevant laboratory practices, techniques, equipment, materials