Process Engineering Specialist (PAT)

Good Health Can’t Wait

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Role Summary

The PAT Specialist (PhD) will contribute to the development, implementation, and lifecycle management of advanced Process Analytical Technology solutions across peptide, oligonucleotide, small-molecule, and drug-product manufacturing processes. This role combines scientific depth, hands-on PAT expertise, chemometrics, and digital analytics to drive real-time process understanding and robust QbD-aligned control strategies.

Key Responsibilities

1. PAT Development & Deployment

• Develop and deploy PAT tools such as Raman, NIR, ATR‑FTIR, UV‑Vis, MS, FBRM, PVM, turbidity, acoustic sensors, and inline LC/MS.
• Support PAT integration in peptide/oligo synthesis, organic reaction monitoring, crystallization, and drug‑product unit operations.• Evaluate, select, and qualify PAT hardware, probes, flow cells, and analytical interfaces.

2. Chemometric Modeling & Advanced Analytics

• Build and validate chemometric models (PCA, PLS, MLR, ANN, MVDA).
• Support integration of models with PAT platforms and automation systems (SynTQ, SIPAT, DeltaV, PCS7).• Maintain model lifecycle management aligned with ICH Q12, digital governance, and data integrity requirements.• Contribute to predictive and hybrid mechanistic–ML model development.

3. Process Understanding & QbD Support

• Use PAT data to define CPPs, CQAs, design space, and robust operating ranges.
• Conduct DoE and multivariate studies on reaction kinetics, crystallization, and synthesis steps.• Contribute to digital twin development and support continuous manufacturing per ICH Q13.

4. Manufacturing Support & Troubleshooting

• Provide technical support during batch execution, investigations, and tech-transfer.
• Troubleshoot PAT instrumentation, probes, spectroscopic signals, and data flow issues.• Collaborate with MSAT, QA/QC, Manufacturing, Automation, and IT teams.

5. Documentation, Regulatory & Compliance

• Prepare method development reports, validation documents, chemometric model files, and eCTD content.
• Ensure compliance with ICH Q8–Q14, 21 CFR Part 11, data integrity, and GMP.• Support regulatory interactions and responses as a technical contributor.

6. Collaboration & Scientific Leadership

• Partner with R&D, Analytical R&D, GMO, MSAT, Digital/IT, and Automation for cross‑functional PAT integration.
• Engage with vendors and academic collaborators for advanced PAT technologies.• Mentor junior engineers and scientists.

Qualifications

E

• PhD in Chemical Engineering, Pharmaceutical Sciences, Analytical Chemistry, Bioprocess Engineering, or related field.

Experience

• 3–6 years total experience (including PhD research and/or industrial/postdoctoral experience).
• Hands-on PAT exposure to spectroscopy, chemometrics, process monitoring, reaction/crystallization, or peptide/oligo processes.

Technical Competencies

• Deep Expertise in at least two PAT techniques (Raman, NIR, FTIR, MS, FBRM, PVM).
• Skilled in SIMCA, Unscrambler, MATLAB, Python, or similar platforms.• Knowledge of ICH Q8–Q14, QbD, MODR, RTRT, CPV, and data integrity.• Familiarity with automation and control system integration.

Behavioral Competencies

• Strong scientific curiosity and problem‑solving mindset.
• Excellent communication, collaboration, and technical writing skills.• Ability to work cross‑functionally and manage multiple projects.

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered