Job Description

Role Objective

Direct and technically manage the Mass Spectrometry and Characterization team to drive analytical deliverables across all biologics projects for regulated and global markets. Lead end-to-end planning and scientific oversight for analytical method development, qualification, technology transfer, biosimilarity assessment, and forced degradation studies while ensuring strict regulatory compliance and data integrity.

Key Responsibilities

Analytical Deliverables Management: Direct and technically manage the Mass Spectrometry and Characterization team to drive analytical deliverables across all biologics projects for regulated and other markets.
End-to-End Scientific Oversight: Lead end-to-end planning and scientific oversight for analytical deliverables, including method development, qualification, technology transfer, biosimilarity assessment, and forced degradation studies.
Mass Spectrometry SME Leadership: Serve as the Subject Matter Expert (SME) overseeing Mass Spectrometry-based analysis for structural characterization.
Strategic Characterization & Data Review:Provide strategic direction and data review for specialized characterization techniques, including mass spectrometry.
Biophysical & HOS Evaluation:Oversee biophysical characterization and Higher Order Structure (HOS) evaluation utilizing DSC, CD, Fluorescence, and FTIR technologies.
Chromatographic Separations:Supervise the development and implementation of chromatographic separation modes as per project characterization requirements.
Team Guidance & Troubleshooting:Guide individual scientists in independent planning, execution, and troubleshooting of all complex MS and characterization activities.
Compliance & Data Integrity:Ensure strict adherence to regulatory systems, established SOPs, and data integrity standards across all mass spectrometry and characterization workflows.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

Interaction with:Direct Reports (Scientists & Analysts), Biologics R&D Project Teams, Quality Assurance (QA), Regulatory Affairs, and Project Management teams.

Nature of Interaction:Technical oversight, experimental guidance, data review and approval, cross-functional project coordination, and regulatory submission support.

Type of Interaction: External

Interaction with:Regulatory bodies/auditors, Contract Research Organizations (CROs), and Analytical Instrument/Technology Vendors.

Nature of Interaction:Regulatory query resolution, technology transfer execution, technical discussions, instrument qualification review, and audit compliance.

Job Requirements

Professional Experience and Relevant Skills:

Experience

M.Sc / M.Tech:Minimum 8 years of relevant industrial experience.

Ph.D.:Minimum 3 years of post-qualification industrial experience.

Core experience working on biotherapeutic proteins like monoclonal antibodies (mAbs) or candidate biosimilars is required.

Skills

Mass spectrometry structural characterization, biophysical characterization, chromatographic method development, forced degradation studies, technology transfer, scientific problem-solving, and team leadership.

Technical Expertise

Method Development and Qualification experience is mandatory.
Specialized expertise in Higher Order Structure (HOS) evaluation using DSC, CD, Fluorescence, and FTIR technologies.
Strong understanding of key analytical deliverables including Critical Quality Attributes (CQA), Quality Target Product Profile (QTPP), Analytical Similarity, Forced Degradation Studies, and Specifications Setting.
Robust knowledge of regulatory compliance, SOPs, and data integrity standards for biologics characterization.

Academic Qualifications & Certifications

Educational Qualification:M.Sc, M.Tech, or Ph.D. in Chemistry, Biochemistry, Biotechnology, Analytical Chemistry, or related Life Sciences disciplines.