Job Description
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Job Title:  PRINCIPAL SCIENTIST
Posting Start Date:  4/6/26
Job Description: 

Company Overview

Role Purpose

The Team Manager – MSAT (Analytics COE – Physicochemical) is responsible for leading and managing the lifecycle of physicochemical analytical methods used for characterization, release, and stability testing of biologics, biosimilars, and/or advanced therapeutics. This role provides deep scientific and technical leadership in HPLC/UPLC, capillary electrophoresis (CE), isoelectric focusing (IEF), mass spectrometry (MS), spectroscopy (UV/Vis, FTIR), particle characterization, and thermal analysis. The individual oversees a team of analytical scientists, ensures method robustness and compliance, and partners closely with MSAT, QC, Regulatory, and Quality teams to support commercial manufacturing, tech transfers, investigations, and inspections.

Academic Stream

0

Work experience (in months)

0

Job Responsibility and key Decisions

Responsibilities

Lead the physicochemical analytics function within the MSAT Analytics COE, managing team operations, project assignments, and resource planning.

Stay updated with all current applicable regulations and guidelines

Provide technical leadership for method development, troubleshooting, and lifecycle management activities.

Oversee analytical support for technology transfers, commercial product launches, and product lifecycle changes.

Partner with QC and Analytical Development to ensure robust, reproducible, and compliant methods in GMP labs.

Support health authority inspections and audits with strong technical justifications, documentation, and method history.

Drive continuous improvement in method performance, laboratory efficiency, and knowledge transfer.

Ensure the alignment of method control strategies with product control strategies and regulatory filings.

Develop and implement training programs and analytical capabilitybuilding initiatives across the MSAT network.

Key Decisions

Approve method validation and transfer strategies, ensuring alignment with product quality and regulatory expectations.

Decide on root cause conclusions and CAPAs for methodrelated deviations and investigations.

Select platforms, instrumentation, and techniques for analytical development or enhancement based on scientific need and risk.

Determine readiness of analytical methods for use in commercial manufacturing and regulatory submissions.

Prioritize technical initiatives, resources, and project timelines across product portfolios and sites.

Make decisions on analytical harmonization across manufacturing sites for consistency and efficiency.
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