Director, Technical Services

Technology Transfer:

• Lead transfer of new products, formulations, and processes into and between sterile and nonsterile compounding, 503B, and peptide API manufacturing sites.
• Own transfer protocols and reports, ensuring process parameters and acceptance criteria are clearly defined and demonstrated.
• Coordinate cross-functionally with R&D, Quality, and Operations for smooth transition to routine production.

Cleaning Validation:

• Own the cleaning validation program across sites, including method development, sampling strategy, and acceptance limit calculations.
• Author and execute protocols and reports for compounding, filling, and API equipment.
• Assess impact of new products or changes and determine revalidation needs.

Process Validation:

• Lead process validation for sterile and nonsterile preparations, aseptic simulations, and peptide API manufacturing.
• Author and execute protocols and reports, define sampling plans and acceptance criteria.
• Own the network-wide program ensuring site-level verification aligns with validated state.

Troubleshooting & Improvement:

• Serve as primary technical resource for diagnosing process deviations, yield losses, and quality issues.
• Lead root-cause investigations and drive corrective actions.
• Identify and lead continuous improvement projects to increase process robustness and consistency.