Manager / Senior Manager, Process Development
About the role
Description:
The role leads process development, optimization, and scale-up activities to support product lifecycle needs. The role includes preparing large quantities of experimental materials for analytical, pharmaceutical, biological, and clinical investigations. The position reviews and resolves issues related to physical properties of bulk products to ensure acceptability against formulation specifications. The role also recommends acquisition and use of new technologies, equipment, and materials, ensuring robust processes, operational readiness, and sustainable manufacturing performance.
Essential Functions:
Lead process development and scale-up for experimental and bulk products
Prepare large-scale experimental batches for analytical and clinical use
Review and resolve physical property issues of bulk materials
Ensure process acceptability against formulation specifications
Drive process optimization, robustness, and efficiency improvements
Apply Quality by Design (QbD) Implementation principles
Support technology transfer to pilot and commercial manufacturing
Recommend new technologies, equipment, and materials
Oversee laboratory operations and cross-functional coordination
Ensure risk management, change control, and audit readiness
Mentor teams and enable innovation and technical problem-solving
Additional Responsibilities:
Education:
B. Pharm B. Pharm - Required
Ph. D. Ph. D. - Preferred
Experience:
15 years or more in 15+ Years
Specialized Knowledge: Licenses:
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