Scientist - Bioassay Development in Rockville, Maryland

Job Title:

Scientist 2 - Bioassay 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.

Your Role:
At Millipore Sigma, as a Scientist 2 - Bioassay Development, you will lead the development and validation of new bioassay methods that expand the current service portfolio and address identified market and client needs. Serving as the primary subject matter expert (SME) in bioassay method development/validation, you will ensure new methods are robust, standardized, and ready for implementation to strengthen portfolio capabilities and address market-driven client needs.

Key Responsibilities:

• Lead development and implementation of new immunoassay methods that expand laboratory capabilities and address gaps in current service offerings.
• Design, optimize, and troubleshoot bioassays to ensure they are fit-for-purpose and aligned with phase-appropriate regulatory expectations.
• Perform hands-on execution and technical leadership across a broad range of modalities, including monoclonal antibodies (mAbs), cell and gene therapy products, antibody-drug conjugates (ADCs), mRNA therapeutics, and viral vectors.
• Keep current on relevant scientific literature, new technologies/capabilities, and support their implementation, as appropriate.
• Identify areas for improvement in current assays, propose and implement solutions
• Act as SME in bioassay methods and provide guidance to analysts and study managers.
• Apply laboratory techniques and skills to complete experiments designed to address a variety of specific problems.
• Prepare/review protocols, reports, SOPs, laboratory records, tech specifications, and other related documents.
• Execute immunological methods in the lab for assay development/validation.
• Perform testing in accordance with SOPs and regulations (cGMP).
• Transfer GMP assays to the 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.
• Maintain strong communication skills to effectively interact with internal and externally stakeholders.
• Performs other duties as assigned.

Minimum Qualifications:

• Ph.D. in a scientific discipline (e.g., Immunology, Cell Biology, etc.), with 3+ years of professional lab experience. OR
• Master's Degree in a scientific discipline (e.g., Immunology, Cell Biology, etc.), with 5+ years of professional lab experience. OR
• Bachelor's Degree in a scientific discipline (e.g., Immunology, Cell Biology, etc.), with 7+ years of professional lab experience.

Preferred Qualifications:

• Experience with the following technical disciplines:
• Microscopy cell imaging.
• Immunophenotyping.
• Cell Sorting.
• dPCR.
• Automation and scale-up experience.
• Experience developing or implementing standardized immunoassay methods that expand laboratory service capabilities.
• Proficiency with ELISA, Flow Cytometry, and qPCR.
• Diverse cell culture knowledge and experience.
• Experience in method development in an immunology laboratory.
• Excellent oral and written communication skills demonstrated through presentations/seminars, oversight of projects, and implementation of new services, etc.
• Excellent time management skills.
• Ability to succeed through collaboration and independently.
• High level of initiative and leadership…