Packaging Development Specialist

We are seeking a highly experienced  Primary Packaging Materials Scientist  to act as a senior Subject Matter Expert (SME) supporting primary packaging activities for parenteral pharmaceutical products.

This is a specialist-level position requiring deep technical expertise in container closure systems (CCS), regulatory documentation, validation, and lifecycle management within a GMP-regulated pharmaceutical manufacturing environment.

Key Responsibilities
Technical Leadership

Lead the design and development of  Container Closure Systems (CCS)  for parenteral drug products

Plan and execute validation studies, including:

Container Closure Integrity (CCI)

Material qualification and verification

Provide technical oversight for lifecycle management of commercial primary packaging materials

Evaluate, qualify, and implement new suppliers

Lead investigations and troubleshooting for packaging-related manufacturing and quality issues

Develop and defend technical strategies to internal and external stakeholders

Key Requirements

MSc or PhD in a relevant Science or Engineering discipline (or equivalent experience)

Extensive experience with  primary packaging materials for parenteral pharmaceutical products

Strong working knowledge of global pharmacopeial requirements (USP, Ph. Eur., JP, Chinese Pharmacopeia)

Container Closure Integrity (CCI)

Validation and verification of primary packaging materials

Demonstrated experience authoring regulatory dossier sections

Significant experience operating within a GMP-regulated pharmaceutical environment

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