Process Engineering Specialist (PAT)

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 ATRFTIR UVVis MS FBRM PVM turbidity acoustic sensors and inline LC/MS.
Support PAT integration in peptide/oligo synthesis organic reaction monitoring crystallization and drugproduct 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 mechanisticML 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 Q8Q14 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 crossfunctional PAT integration.
Engage with vendors and academic collaborators for advanced PAT technologies.
Mentor junior engineers and scientists.

Qualifications :

Education

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

Experience

36 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 Q8Q14 QbD MODR RTRT CPV and data integrity.
Familiarity with automation and control system integration.

Behavioral Competencies

Strong scientific curiosity and problemsolving mindset.
Excellent communication collaboration and technical writing skills.
Ability to work crossfunctionally and manage multiple projects.

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at

Remote Work :

No

Employment Type :

Full-time