Process Development Specialist

Job Summary
We are seeking a dynamic and experienced Specialist in Process Development in the pharmaceutical development process responsible for strategy evaluations process design optimization scale-up calculations and handling exhibit batches. This role involves working on oral solid formulations and technical documentation as well as process validations to ensure the successful development and scale-up of pharmaceutical products.

Roles & Responsibilities

• You will be responsible to Conduct strategy evaluations to design and optimize pharmaceutical processes ensuring efficient and cost-effective development using Continuous Manufacturing.
• You will be responsible to Calculate batch sizes for both early development and commercial production considering critical parameters and quality standards.
• You will be responsible to Lead process development activities for API synthesis using Flow synthesis from concept to commercialization including the design of experiments and formulation strategies.
• You will be responsible to Perform scale-up calculations and execute scale-up processes to ensure successful transition from lab-scale to production-scale.
• You will be responsible to Handle exhibit batches coordinating activities and documentation to meet regulatory requirements and project timelines for Flow pipeline projects.
• You will be responsible to Prepare and maintain technical documentation including development reports process validation protocols and regulatory filings.
• You will be responsible to Collaborate with cross-functional teams to drive process improvements troubleshoot issues and ensure product quality and consistency.
• You will be responsible to Stay updated with industry trends and regulatory guidelines incorporating best practices and innovative technologies into the Flow development process. 

Qualifications :

Educational qualification: Masters in pharma/Biotechnology/Chemistry

Minimum work experience: 12 years  of Experience in Process Development/Manufacturing

Skills & attributes:
Technical Skills

• Experience in process optimization development and troubleshooting in relevant dosage forms or technologies 
• Hands-on experience in end-to-end scale up
• Depth understanding of process techniques & equipment knowledge
• Knowledge on Deficiency management and product validations.
• Experience in manufacturing process improvement.
• Experience with Flow chemistry and Continuous Manufacturing
•  

Behavioral Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Performance oriented and good at building leveraging relationship.
• Ability to work collaboratively with own team and cross-functional teams. 

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