Packaging Strategy Lead — Associate Director, Biopharma

Caraway Therapeutics, Inc.; Rahway (NJ); On-site; USD 129,000 - 203,000; Full time

Job summary

Merck is seeking an Associate Director of Packaging to define and execute global packaging strategies. The role leads technical risk assessments, packaging specifications, and qualification activities while ensuring regulatory compliance and sustainability goals.

The successful candidate will have expertise in primary, secondary, and tertiary packaging systems, including blow-fill-seal technologies, and will collaborate across CMC teams to bring new products to market.

Qualifications

• Bachelor of Science in Packaging Engineering or related field with 10 years of pharma development experience, or MS/PhD with 8 years.
• Understanding of pharmaceutical development processes and packaging components; ability to design and test packaging elements.
• Experience with risk assessment tools and leading cross-functional teams; strong communication skills.
• Knowledge of current US/global regulations, ICH, ISO standards, and quality systems for packaging.

Responsibilities

• Define and execute packaging strategies meeting global network needs.
• Lead technical risk assessments, develop packaging specifications, and oversee qualifications.
• Ensure compliance with regulatory standards and sustainability goals.
• Represent stakeholders and balance interests across functions.
• Collaborate across the end-to-end CMC continuum to develop new products.

Skills

Coordinate

Change Management

Collaborative Leadership

Cross-Functional Teamwork

Detail-Oriented

Deviation Management

Engineering Standards

Global Coordination

GMP

ISO Compliance

Packaging Engineering

Procedure Writing

Process Definition

Process Optimization

Project Leadership

Project Management Leadership

Project Team Management

Education

B.S. in Packaging Engineering

M.S./Ph.D. in relevant field

Tools

Blow-fill-seal tech

Job description

Merck is seeking an Associate Director of Packaging to define and execute global packaging strategies. The role leads technical risk assessments, packaging specifications, and qualification activities while ensuring regulatory compliance and sustainability goals.

The successful candidate will have expertise in primary, secondary, and tertiary packaging systems, including blow-fill-seal technologies, and will collaborate across CMC teams to bring new products to market.