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Specialist– Ms&T

Novartis
Novartis
5-9 years
Not Disclosed
Hyderabad
1 May 6, 2026
Job Description
Job Type: Full Time Education: Master's degree in biotechnology, Pharmacy, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience. Skills: Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process

Specialist – MS&T (Manufacturing Science & Technology)

Location: Hyderabad (Office)
Job Type: Full-Time
Experience Required: 5–9 Years
Industry: Pharmaceutical / Biologics / Life Sciences
Department: Manufacturing Science & Technology (MS&T)


Job Overview

We are looking for an experienced and technically skilled Specialist – MS&T to support biologics manufacturing operations and technical development activities within a large molecules platform. The selected candidate will collaborate with cross-functional technical operations teams to drive process validation, transport validation, extractables & leachables assessments, risk management, and manufacturing support activities.

This role is ideal for professionals with strong expertise in biologics drug substance manufacturing, process validation, cleaning validation, and regulatory compliance within pharmaceutical or biotechnology environments.


Key Responsibilities

Validation & Technical Operations

  • Prepare and manage:
    • Process Validation Protocols & Reports
    • Cleaning Validation Documentation
    • Transport Validation & Verification Protocols
    • Ongoing Process Verification (OPV) Plans & Reports
  • Conduct validation studies in coordination with cross-functional teams and ensure all collected data is accurate, complete, and compliant with regulatory standards.
  • Support manufacturing process transfer activities by preparing technical transfer protocols and reports.

Risk Assessment & Compliance

  • Perform risk assessments related to:
    • Physico-chemical buffer stability
    • Corrosive agents
    • Nitrosamines
    • Raw materials
    • Residual solvents
    • Elemental impurities
  • Monitor raw material compliance alerts including:
    • ß-Lactam structure evaluations
    • EG/DEG monitoring
  • Support Hazard Analysis Critical Control Point (HACCP) preparation and updates.
  • Ensure alignment with regulatory guidance on:
    • Product validation
    • Product filing
    • Post-approval changes
    • GMP/GDP compliance

Extractables & Leachables (E&L)

  • Conduct Extractables & Leachables (E&L) risk assessments.
  • Coordinate E&L studies with suppliers and cross-functional stakeholders.
  • Gather and maintain E&L documentation for regulatory audits and toxicological assessments.
  • Ensure accountability and audit readiness for E&L activities at the site level.

Process Monitoring & Continuous Improvement

  • Perform OPV/CPV evaluations and analyze process performance trends.
  • Provide technical recommendations and process insights to the MS&T team.
  • Drive operational excellence and continuous improvement initiatives across manufacturing and validation processes.
  • Ensure timely preparation and availability of technical documentation according to organizational guidelines.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Master’s Degree in:
    • Biotechnology
    • Pharmacy
    • Chemistry
    • Biochemistry
    • Life Sciences
    • Or equivalent scientific disciplines

Preferred Qualification:

  • MSc/MS or equivalent advanced qualification in relevant science streams