Manager /Sr. Manager/AGM- SME (Granulation )

Client: Leading Pharmaceutical Company

Location: Multiple Sites (with 50% travel)

Role Overview

We are seeking highly experienced Subject Matter Experts (SMEs) across key manufacturing domains: Granulation Operations. Each SME will be responsible for providing deep technical expertise, process optimization, and compliance oversight in their respective area. The role requires extensive travel (~50%) to support multiple facilities, audits, and technology transfers.

Key Responsibilities (per area)

SME – Granulation

• Oversee wet and dry granulation processes, ensuring robust scale-up and reproducibility.


• Optimize granulation parameters across different equipment models.


• Support technology transfer and harmonization across sites.


• Conduct training and audits to ensure compliance.

Common Responsibilities

• Travel (~50%) to our facilities for audits, training, troubleshooting, and technology transfer.


• Collaborate with R&D, QA, and manufacturing teams to ensure process excellence.


• Author and review technical documentation, validation protocols, and reports.


• Ensure compliance with global regulatory standards (FDA, EMA, WHO).


• Mentor and train operators and technical staff.

Qualifications

• Bachelor’s/Master’s in Pharmacy, Biotechnology, Chemical/Mechanical Engineering, or related discipline.


• 8–12 years of hands-on experience in the respective domain (Compression, Granulation, ).


• Proven expertise working with different makes/models of equipment or directly with OEMs.


• Strong knowledge of cGMP, regulatory requirements, and validation practices.


• Excellent communication, analytical, and cross-functional collaboration skills.


• Willingness to travel up to 50% of the time.