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

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: Compression 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 – Compression

• Lead process design, scale-up, and troubleshooting for tablet compression.
• Provide expertise on different makes/models of compression equipment, including OEM systems.
• Develop SOPs, batch records, and validation protocols.
• Train operators and ensure compliance with cGMP and regulatory standards.

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.