Process Development Specialist

Job Summary

• 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. 

Educational qualification:

• 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. 

About the Department

Integrated Product Development Organisation

Benefits Offered