PHARMAFull-time
Senior Scientist - Mass Spectrometry (LC-MS)
By Admin · Research & Development (Lab & Science)
INDIA (IN)ONSITEPOSTED: 9/9/2026
PHARMAFull-time
HIRING ORGANIZATIONBIOPHARMACEUTICAL COMPANYBiosciences
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Lead biotherapeutic product characterization using advanced LC-MS workflows to support biosimilarity studies, comparability assessments, and regulatory filings.
Plan, execute, and oversee complex experimental designs for method development, method qualification, and analytical characterization of biologics and biosimilars.
Draft, review, and finalize scientific reports, characterization packages, and presentation decks for CMC and Regulatory Affairs (RA) dossier submissions.
Mentor and train team members on sample preparation techniques, LC-MS instrumentation, advanced data interpretation, and DQA standard operating procedures (SOPs).
Provide cross-functional analytical support for impurity characterization, structural elucidation, and post-translational modification (PTM) profiling.
Evaluate and procure next-generation analytical instruments and technologies to enhance in-house scientific and analytical capabilities.
Ensure strict adherence to quality systems and regulatory compliance, managing CAPA, Change Control (CC), and Deviation workflows within the analytical laboratory.
Comply with all EHS, safety norms, and KAVACH safety policy frameworks.
Technical & Domain Standards
Maintain high-level expertise in liquid chromatography-mass spectrometry (LC-MS/MS) applications including intact mass analysis, peptide mapping, glycan profiling, and charge variant characterization.
Operate in compliance with biopharmaceutical Quality Management Systems (QMS), Quality by Design (QbD) principles, and regulatory guidelines (ICH Q6B, FDA, EMA).
Leadership & Business Impact
Guide cross-functional project teams across CMC, Regulatory, and R&D functions to ensure timely delivery of analytical dossiers.
Foster team skill development, innovation, process excellence, and strategic capability building in biopharmaceutical characterization.
Benefits & Total Rewards
Executive biopharmaceutical R&D role offering high scientific visibility in biosimilar development.
Competitive compensation package with comprehensive healthcare coverage and professional development opportunities.
REQUIRED VERIFIED SKILLS
LC-MS
Biosimilarity Studies
Product Characterization
Method Development
Method Qualification
CMC Dossier Preparation
Impurity Characterization
CAPA
Change Control
Deviations
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Salaries for senior mass spectrometry biopharmaceutical scientists with 5–10 years of experience (or PhD holders) in Indian biotechnology hubs reflect competitive top-tier R&D market rates, supplemented by annual performance incentives, health benefits, and research support.
ORGANIZATION CONTEXT & CULTURE
Biopharmaceutical Company is actively hiring for this position.
INDUSTRY: Biosciences
EXPECTED CAREER ROADMAP
This senior analytical role places scientists on a high-growth trajectory toward Principal Scientist, Head of Analytical R&D, or Lead CMC Regulatory Strategist. The deep exposure to biosimilarity assessment, LC-MS technologies, and dossier submissions opens global opportunities across biopharmaceutical R&D, contract research organizations (CROs), and regulatory agencies.
APPLICATION ADVISORY
Highlight specific hands-on experience with biosimilar characterization, intact mass, peptide mapping, and LC-MS method qualification in your CV. Be prepared to discuss your experience writing CMC report sections, managing QMS quality events (CAPA/Deviations), and mentoring junior analysts during technical interviews.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.