Technical Expert MS&T Bio Similar/ Large Molecules DS/DP

IN04 (FCRS = IN004) Sandoz Private Limited; Telangana; On-site; INR 1,200,000 - 2,200,000; Full time

Benefits offered by this job

Flexible working arrangements

Learning and development opportunities

Supportive and inclusive culture

Job summary

Sandoz Private Limited is seeking a Technical Expert in Telangana, India, to serve as a primary technical interface between Bio Manufacturing sites and the Global MS&T Capability Hub. The role focuses on ensuring robust process performance, product quality, and regulatory compliance throughout the product lifecycle.

The ideal candidate will have 8-12 years of experience in biologics manufacturing, strong regulatory knowledge, and exceptional communication skills.

Qualifications

• 8-12 years of relevant experience in biologics manufacturing.
• Post-graduate degree in a relevant field; Ph.D. preferred.
• Fluent in English and local languages.

Responsibilities

• Act as Technical Expert for assigned manufacturing sites.
• Apply science- and risk-based approaches to product quality.
• Lead design and control optimization projects.

Skills

Biologics manufacturing

Regulatory guidelines knowledge (USFDA, EMA, ICH, ASTM, SUPAC)

QbD, DoE, Minitab, and statistical analysis

Excellent communication

Cross-functional collaboration

Education

Post-graduate degree in Pharmacy, Biology, Biotechnology, or related life science

Ph.D. in Pharmaceutical Technology

Job description

Job Description Summary

Sandoz is a global leader in sustainable biosimilar and generic medicines. The Technical Expert will serve as the primary technical interface between Sandoz Bio Manufacturing sites and the Global MS&T Capability Hub for Large Molecule Drug Substance & Product operations, ensuring robust process performance, product quality, and regulatory compliance across the product lifecycle.

Key Responsibilities

• Act as Technical Expert for assigned internal manufacturing sites or CMOs, ensuring process capability and maintaining products in a validated state.
• Apply science‑ and risk‑based approaches to ensure sustainable product quality and availability of all relevant technical documentation.
• Maintain oversight and deep understanding of the entire manufacturing process across the product lifecycle; identify and monitor CQAs, CMAs, and CPPs.
• Analyze manufacturing data (OPV, CPV, APQR) to assess state of control and recommend improvements.
• Evaluate technical changes, assess feasibility, and define scope/design of technical batches; contribute to registration strategy and align regulatory timelines.
• Lead or support root cause investigations for product/process failures and drive remediation or improvement initiatives.
• Collaborate cross‑functionally with Quality, Operations, Engineering, and Development teams, sharing best practices and lessons learned across divisions and sites.
• Define and implement validation strategies and supporting documentation; maintain validation oversight and review QRAs, ensuring products remain in a validated state.
• Support creation and review of validation protocols and reports; contribute to revalidation planning and documentation.
• Participate in supplier/product evaluation and selection processes; gather and document technical information on manufacturing capabilities of sites/CMOs.
• Provide data and documentation for tech transfer activities; define product acceptance criteria and monitor performance post-transfer.
• Ensure successful, well‑documented product transfers and launches; actively support governance processes for product launch and transfer.
• Interface with Development to ensure new products and processes are designed for commercial scalability and lifecycle sustainability; provide input at formal stage gates.
• Support development of control strategies that meet regulatory and operational requirements.
• Lead design and control optimization projects to improve process robustness and sustainability; prepare high‑quality design and operational documents.
• Own and maintain the training curriculum relevant to the technical role.
• Actively support the Technical Expert in conducting technical due diligence during the pre‑evaluation phase, in collaboration with BD&L, to identify suitable external suppliers.

Minimum Requirements & Qualifications

• 8‑12 years of relevant experience in biologics manufacturing, including cell culture, fermentation, purification, and formulation processes.
• Post‑graduate degree in Pharmacy, Biology, Biotechnology, or a related life science field; Ph.D. in Pharmaceutical Technology preferred.
• Fluent in English and local language(s) of the region.
• Strong knowledge of regulatory guidelines: USFDA, EMA, ICH, ASTM, SUPAC.
• Expertise in QbD, DoE, Minitab, and statistical analysis.
• Ability to prepare high‑quality design and operational documents for equipment qualification, verification, and continuous process validation.
• Excellent communication and cross‑functional collaboration skills.
• Ability to manage multiple complex projects in a global matrix environment.

Benefits

Flexible working arrangements, learning and development opportunities, and a supportive, inclusive culture that values diversity and personal growth.