Associate Director Packaging Development
Core
Senior individual contributor providing technical leadership for packaging development, qualification, and commercialization of combination products (biologics and oral solid dose).
Role type
Senior IC packaging development engineer (combination products)
Builds
Packaging systems for biologics and OSD combination products
Domain
Pharmaceutical/Combination product packaging engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
packaging engineering, package development, qualification methodologies, combination product development, cGMP, design controls, risk management, change control, regulatory submissions (NDA/BLA), CMO management, project management
Preferred skills
biologics packaging systems, cold chain distribution, transportation qualification, traditional pharmaceutical packaging (OSD), FDA combination product requirements, EU MDR, ISO 11607, ISO 14971, 21 CFR Parts 210/211/820, ASTM/ISTA standards
Technologies
None explicitly listed beyond standards and regulations
Responsibilities
Define packaging strategies for regulatory submissions and commercialization; establish governance and operating frameworks for Packaging Engineering; lead packaging development, qualification, and commercialization activities; author technical documents and regulatory submission sections; mentor packaging engineers; evaluate packaging materials, equipment, and CMOs.
Seniority
Senior, hands-on IC
