Senior Expert Science & Technology

Novartis AG; Hyderabad; On-site; INR 2,000,000 - 3,200,000; Full time

Job summary

Novartis Healthcare Private Limited, Hyderabad, India, is seeking a senior scientist to lead analytical development for DS/DP, with focus on late-phase method validation, dissolution, and chromatography. The role requires strong GMP experience, regulatory awareness, and leadership within a multidisciplinary team.

You will design and execute analytical experiments, develop robust methods, and mentor junior staff while ensuring high-quality documentation and collaboration with global teams.

Qualifications

• Ph.D. in Analytical Chemistry (or related) with minimum 5 years of experience, or Master’s with minimum 12 years in pharma analytical development.
• Strong understanding of Analytical Control Strategy, method lifecycle, CQAs and regulatory requirements.
• Experience with USP/EP/JP dissolution requirements and dissolution method development/validation.

Responsibilities

• Provide scientific leadership for late-phase analytical method validation and regulatory compliance.
• Lead the design, planning, execution, interpretation and reporting of analytical activities for DS/DP.
• Develop and validate robust analytical methodologies for oral solid dosage forms; apply chromatography, dissolution testing and statistics.
• Mentor teammates and contribute to knowledge sharing across analytical project teams.
• Prepare analytical documentation for handovers, health authority responses, CMC modules, and manufacturing requirements.

Skills

Analytical Chemistry

Team leadership

Regulatory compliance

GMP experience

Chromatography

Dissolution testing

Mass spectrometry

Data analysis

Documentation writing

Education

PhD in Analytical Chemistry

MSc in Chemistry/Pharmacy

Tools

LIMS

Chromeleon

Mass spectrometry software

Job description

Summary-Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures. Lead and manage all project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals. -Management Track -Lead a team for the development of pharmaceutical/biological/cell-gene therapies working in a multidisciplinary environment. Execute and support developing the functional strategy and drive operational excellence in line with TRD vision and strategy. Ensure full portfolio support in line with GDD, NTO and NIBR plansLead and manage all project/local network activities and contribute to strategic decisions; design, plan, perform, -document and interpret scientific/developmental experiments or GMP testing or pilot plant processes for the preparation and timely delivery of generic products, processes or procedures within a multifunctional project team coordinated by a Project Manager/Leader; maintain and qualify equipment/infrastructure and manage operational aspects in lab or plant as assigned.About the RoleMajor accountabilities:· Provide scientific leadership for late-phase analytical method validation, ensuring regulatory compliance and successful delivery of drug development programs, with hands-on experience in New Chemical Entity (NCE).· Be responsible for optimizing and validating robust analytical methodologies for oral solid dosage forms. Strong expertise in chromatography, dissolution testing and statistical tools is required.· Design, plan, execute, interpret, and report analytical activities for drug substance (DS) and/or drug product (DP), applying state-of-the-art analytical science and technologies (e.g., analytical method development, validation, transfer, stability studies, release testing, and formulation development analytics) in accordance with agreed timelines and quality standards.· Contribute to the planning and execution of laboratory experiments for assigned projects, including activity scheduling, experimental design, data evaluation, and interpretation.· Author analytical documents that support analytical and global project strategies throughout the project lifecycle. Contribute to strategic decision-making through the design, planning, and execution of analytical activities.· Support the preparation of analytical documentation for handover to internal and external partners, including responses to health authority questions, CMC modules, and Manufacturing & Supply Operations requirements.· Share best practices and provide strong scientific and technical expertise within analytical project sub-teams, among analytical scientists, and across the broader organization.· Ensure compliance with applicable SOPs, GMP, GLP, Quality Management (QM), Health, Safety & Environment (HSE), ISRM, and Novartis guidelines.· Demonstrate a strong team spirit and foster knowledge sharing. Embrace Novartis Values and Behaviors while coaching and mentoring project team members and other associates.· Develop, mentor, and coach scientific associates; present scientific and technical results internally; and contribute to scientific publications, presentations, and patent applications.Essential RequirementPh.D. in Analytical Chemistry (or a related discipline) with a minimum of 5 years of relevant experience, or a Master’s degree in chemistry, Pharmacy, or a related field with a minimum of 12 years of experience in pharmaceutical analytical development.Strong understanding of Analytical Control Strategy, method lifecycle management, CQAs, specifications, and regulatory requirements.Strong knowledge of USP/EP/JP dissolution requirements, with expertise in dissolution method development, optimization, validation, and application to formulation development, process understanding, and stability studies.Experience in mass spectrometry is considered an asset. Demonstrated contribution to scientific exchange and knowledge‑sharing groups within Novartis.Strong scientific capability with a proven track record of guiding and mentoring colleagues. Proficiency with software and digital tools, including MS Office, LIMS, and chromatography data systems (e.g., Chromeleon).Solid GMP experience (mandatory).Sound understanding of regulatory and quality expectations.Strong scientific foundation with excellent communication skills, including presentations and scientific/technical writing.Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.Read our handbook (PDF 30 MB)DivisionDevelopmentBusiness UnitDevelopmentLocationIndiaSiteHyderabad (Office)Company / Legal EntityIN10 (FCRS = IN010) Novartis Healthcare Private LimitedFunctional AreaResearch & DevelopmentJob TypeFull timeEmployment TypeRegularShift WorkNoAccessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.