API R&D Tech Lead (CIP)

Job Summary

This role is for a process chemistry leader responsible for defining non-infringing API routes and driving end-to-end process development from feasibility to commercialization. The role focuses on route selection cost strategy and alignment with IP regulatory and sourcing requirements. You will lead process optimization using QbD principles to develop safe scalable and cost-effective manufacturing processes. The position involves close collaboration with cross-functional teams to ensure seamless tech transfer and plant execution. You will monitor plant performance troubleshoot scale-up issues and ensure compliance with quality and regulatory standards. Additionally the role includes supporting DMF filings addressing deficiencies and driving innovation. Mentoring teams and managing project execution across multiple products are key expectations.

Roles & Responsibilities

You will be responsible for defining non-infringing route selection strategies through literature evaluation risk assessment and alignment with IP RA SCM and portfolio teams.

You will be responsible for driving feasibility optimization and execution of cost-effective efficient and green synthetic routes.

You will be responsible for planning and executing experiments using QbD principles to develop robust safe and scalable processes.

You will be responsible for leading cross-functional coordination phase gate reviews and ensuring timely project progression.

You will be responsible for supporting tech transfer monitoring plant performance and troubleshooting scale-up and commercial batch issues.

You will be responsible for ensuring regulatory compliance including DMF documentation impurity control and response to deficiencies.

You will be responsible for defining specifications control strategies and ensuring toxicological and safety assessments (e.g. genotoxicity nitrosamines).

You will be responsible for mentoring teams driving innovation and supporting intellectual property and technology development.

Qualifications :

Educational qualification: Post Graduation in Organic Chemistry Process Chemistry Chemical Engineering or related field is mandatory.

Ph.D. in Organic Chemistry Process Engineering or related field is preferred.

Certification in Advanced Process Chemistry Regulatory Affairs for APIs or related field is preferred.

Minimum work experience:

10/ 12 years of experience

Skills & attributes &Critical exposures

Functional Skills

Process Development

Green Chemistry

Feasibility Studies

Scale-Up Process Management

Technology Transfer

Data Analysis

Project Management

Intellectual Property Strategy

Resident Skills

Digital Transformation

Quality By Design (QbD)

Drug Development

Regulatory Compliance

Lean Methodologies

Behavioural Skills

Strong strategic thinking with execution focus

Effective cross-functional leadership and stakeholder management

Coaching mindset with focus on team capability building

Critical exposures

Experience in synthetic route strategy design via advanced patent mining route feasibility benchmarking and integration of sourcing IP and cost-risk inputs for multi-project planning is desired.

Experience in scalable API process development with impurity profiling and lab-to-plant reproducibility is desired.

Experience in specification definition for KSMs intermediates and APIs with technical review of development characterization and regulatory documentation is desired.

Experience in commercial batch troubleshooting and lifecycle process management with alignment to regulatory and filing timelines is desired.

Exposure in API-formulation interface polymorph selection and impurity synthesis for regulatory response is preferred.

Additional Information :

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 Work :

No

Employment Type :

Full-time