Associate Director – TSMS Dry External Manufacturing

About the role

The Associate Director – Technical Services/Manufacturing Science (TS/MS) Dry Products External Manufacturing leads the technical and engineering oversight of external dry‑product manufacturing for Lilly. This senior position balances staff coaching, production support, technical projects, transfers, commercialization, and process optimization.

Key responsibilities

• Manage TS/MS and engineering personnel supporting external dry‑product manufacturing.
• Provide technical review and approval for investigations, change controls, regulatory submissions, validations, annual product reviews, manufacturing tickets, procedures, and control strategies.
• Partner with TS/MS, engineering, and cross‑functional teams to align technical agenda with site business plans and GMP quality objectives.
• Ensure oversight of oral solid dose form manufacturing, including spray‑dried and amorphous solid dispersions.
• Interact with regulators, customers, and auditors on business issues and audit support.
• Define strategic direction to improve process control, yield, and productivity.

Required profile

• Extensive knowledge of cGMPs and global regulatory manufacturing guidance.
• Experience with validation, engineering practices, and technical documentation.
• Proven ability to lead and develop technical and engineering staff.
• Strong cross‑functional collaboration skills across sites, networks, and contract manufacturers.

Required skills

• cGMP compliance
• Process validation
• Technical documentation review
• Manufacturing process oversight
• Process optimization
• Oral solid dose manufacturing
• Spray‑dried dispersion technology