Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Expert Science &Technology

Novartis
8+ years
Not Disclosed
Hyderabad
9 May 20, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company: Novartis
Novartis Official Website
Location: Hyderabad (Genome Valley / TRD Office)
Employment Type: Full-time
Requisition ID: REQ-10076531
Application Deadline: May 30, 2026


1. Role Overview

The Expert Science & Technology role focuses on analytical development for advanced therapeutic modalities, particularly oligonucleotides and peptide-based drugs.

The position bridges analytical science and clinical development by designing, executing, and validating robust analytical methods that ensure drug quality, safety, and regulatory compliance.


2. Core Responsibilities

A. Analytical Method Development & Validation

  • Design and execute analytical feasibility studies

  • Develop, validate, and transfer analytical methods for:

    • Oligonucleotides

    • Peptide therapeutics

  • Apply chromatography and mass spectrometry techniques for biological molecules

  • Ensure methods are robust, reproducible, and regulatory compliant


B. Laboratory Execution & Scientific Studies

  • Plan and perform laboratory experiments including:

    • Method development and validation

    • Stability studies

    • Release testing

    • Formulation analytics

  • Document all experimental work according to quality standards and timelines


C. Data Integrity & Regulatory Compliance

  • Ensure accurate data entry into systems (e.g., LIMS)

  • Maintain Good Documentation Practices (GDP) and Good Laboratory Practices (GLP)

  • Support audits and ensure compliance with regulatory expectations

  • Manage deviations, OOS/OOT investigations, and change controls


D. Laboratory Operations & Resource Management

  • Manage laboratory materials, consumables, reagents, and equipment

  • Maintain efficient and compliant lab operations

  • Implement lean and sustainable laboratory practices


E. Scientific Interpretation & Communication

  • Analyze and interpret experimental data

  • Communicate findings, issues, and risks to project teams

  • Support scientific and technical writing for reports and submissions

  • Present data in internal and cross-functional meetings


F. Performance & Quality Management

  • Meet defined Key Quality Indicators (KQI) and Key Performance Indicators (KPI)

  • Support internal and external audits

  • Ensure no critical compliance findings within scope of work


3. Required Qualifications

Education

  • PhD in Analytical Chemistry (1–3 years experience), OR

  • M.Pharm / M.Sc. with 8+ years of pharmaceutical analytical development experience


Experience

  • Strong experience in analytical development within pharma industry

  • Expertise in oligonucleotide and/or peptide analytics preferred

  • Hands-on experience in GMP laboratory environments


Technical Expertise

  • Chromatography techniques:

    • RP (Reverse Phase)

    • IEX (Ion Exchange)

    • HILIC (Hydrophilic Interaction Chromatography)

  • Mass spectrometry (qualitative & quantitative analysis)

  • Chromatography data systems (e.g., Chromeleon)

  • LIMS systems and data reporting tools


4. Core Skills

Scientific & Technical Skills

  • Analytical method development and validation

  • Experimental design and execution

  • Pharmaceutical quality control and testing

  • Data interpretation and troubleshooting


Compliance & Quality Skills

  • GMP / GLP compliance

  • SOP adherence

  • Deviation and OOS investigation

  • Regulatory-quality documentation


Operational Skills

  • Laboratory management and resource planning

  • Data integrity and reporting systems

  • KPI/KQI tracking and performance delivery


Behavioral Skills

  • Strong scientific communication

  • Problem-solving and analytical thinking

  • Attention to detail

  • Cross-functional collaboration

  • Time and priority management


5. Key Skill Areas (From JD Keywords)

  • Analytical Chemistry & Method Development

  • Chromatography & Mass Spectrometry

  • GMP/GLP Laboratory Compliance

  • Technical Writing & Scientific Documentation

  • Experimental Design & Process Simulation

  • Health, Safety & Laboratory Standards


6. Organizational Context

This role is part of the Technical Research & Development (TRD) organization within Global Drug Development. It plays a key role in ensuring that advanced therapeutic molecules meet stringent analytical and regulatory standards before progressing into clinical development.