Job Description

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.

Skills Required