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Merck · 7 hours ago

Associate Director, Engineering- Small Molecule

USA - New Jersey - Rahway

Full-time

Hybrid

Lead/Staff, Director/Executive

$129K/yr - $203K/yr

8+ years exp

Merck is a leading pharmaceutical company seeking an Associate Director of Engineering for Packaging Commercialization. This role involves leading packaging development for new pharmaceutical products, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to optimize packaging strategies.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Lead packaging development for new oral solid dosage and parenteral products in our small molecule portfolio

Collaborate with stakeholders across the end-to-end continuum of CMC areas

Define and execute overall packaging strategies that meet global network needs

Ensure packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs

Ensure activities supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch

Accountable for technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals

Lead with ownership and accountability for representing, communicating, and balancing the interests of stakeholders

Effectively drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups

Qualification

Small Molecule LeadershipPharmaceutical DevelopmentPackaging EngineeringProject ManagementRisk Assessment ToolsRegulatory KnowledgeCross-Functional TeamworkTechnical LeadershipManufacturing PracticesProcess OptimizationRoot Cause AnalysisInterpersonal Skills

Required

Bachelor of Science (B.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience; OR Master of Science (M.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with eight (8) years of relevant pharmaceutical development experience

Small molecule portfolio leadership, with experience supporting small molecule portfolio across oral solid dosage forms (tablets, capsules)

Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components

Demonstrated understanding of the use of Risk Assessment tools

Demonstrated ability to work both independently and as part of a larger team

Demonstrated experience in leading cross-functional groups both internally and externally

Demonstrated project management experience and ability to provide technical leadership for complex projects while managing multiple projects in a fast-paced environment

Excellent technical written and oral communication skills that support presentation of information clearly and concisely for all levels of the organization

Demonstrated knowledge of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging

Strong interpersonal skills and the demonstrated ability to influence senior leaders

Ability to manage complex programs and support multiple activities/projects

Willingness to grow and learn all areas of Pharmaceutical new product development