Scientist 1 - Analytical Development

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

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.

Key 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.

 

Who You Are

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

 

Preferred Qualifications:

Broad working knowledge of the field, with experience in relevant laboratory practices, techniques, equipment, materials, and mathematical calculations.

Intermediate skills in applicable computer programs.

Experience with analytical method development in a pharmaceutical, biotechnology, or related laboratory environment.

Excellent oral and written communication skills demonstrated through technical presentations, project leadership, implementation of new services, and cross-functional collaboration, etc.

Excellent time management skills, with the ability to manage multiple priorities effectively.

Highly collaborative as well as independent.

Demonstrate a high level of initiative, leadership, and problem-solving capabilities.

Effective coaching and training skills for complex and highly technical work.

Experience with some or all of the following technical disciplines:

Liquid Chromatography (HPLC; e.g., SEC, RP, IEX, and residual/impurity 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).

Pay Range for this position - $75,000 - $112,000

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .

RSREMD

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!