API R&D Tech Lead (CIP)

Job Description

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. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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 https://careers.drreddys.com/#!/"