Scientist 2 - Analytical Development

Merck•Rockville, MD

1d•Onsite

About The Position

As a Scientist 2 - Analytical Development at MilliporeSigma you will lead the development and validation of new analytical methods that expand the current service portfolio and address identified market and client needs. Serving as the primary subject matter expert (SME) in analytical 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.

Requirements

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

Nice To Haves

Experience with: Liquid Chromatography (HPLC; e.g., SEC, RP, IEX, and residual testing).
Mass Spectrometry (Intact Molecular Weight, Peptide Mapping, Disulfide Mapping, Glycan Profiling, N-/C-Terminal Sequencing).
Capillary Electrophoresis Methods (CE-SDS, cIEF).
Compendial assays and alternative methods (e.g., container closure integrity-related methods).
Particle sizing and characterization methods (e.g., DLS).
Mass photometry.
Experience developing or implementing standardized analytical methods that expand laboratory service capabilities.
Experience in method development in a pharmaceutical laboratory.
Excellent oral and written communication skills demonstrated through presentations/seminars, oversight of projects, implementation of new services, etc.
Excellent time management skills.
Ability to succeed through collaboration and independently.
High level of initiative and leadership capabilities.
Effective coaching and training skills for complex and highly technical work.

Responsibilities

Lead development and implementation of new analytical methods that expand laboratory capabilities and address gaps in current service offerings.
Design, optimize, and troubleshoot analytical assays 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 and propose and implement solutions.
Act as SME in analytical 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 analytical 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 external stakeholders.
Perform other duties as assigned.