Manager Sr. ManagerAGM- SME (granulation Compression, Injectable Packing )

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 Granulation Packing (Blister Bottle Vial Filling Secondary) and Lyophilizer 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.

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.

SME – Packing (Blister Bottle Vial Filling Secondary)

• Provide technical leadership in primary and secondary packaging operations.
• Expertise in blister lines bottle filling vial filling and secondary packaging equipment from multiple OEMs.
• Drive serialization track-and-trace and packaging compliance initiatives.
• Standardize packaging practices across facilities and train site teams.

SME – Lyophilizer (Freeze Drying)

• Lead lyophilization cycle development optimization and troubleshooting.
• Provide expertise on lyophilizer equipment from different OEMs.
• Ensure aseptic compliance and sterile manufacturing standards.
• Train site teams on lyophilizer operation cleaning and maintenance.

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 Packing Lyophilizer).
• 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.

Required Skills:

EngineeringProjectsCompressionGranulationLyophilliserBlister PackingVial Filling