Associate Director, Engineering

Job Description

At our company, we are dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. We are seeking a passionate and experienced Associate Director of Engineering to join our team. This role offers a unique opportunity to contribute to the development of cutting-edge biologic and vaccine drug substances, drug products, and medical device combination products. If you are driven by the power of leading-edge science and want to make a meaningful impact on global health, we invite you to apply.

Responsibilities:

• Provide technical expertise from initial design concept through product launch with a primary focus on biologic and vaccine drug substances, drug products, and medical device combination products (MDCPs).

• Influence oral solid dosage form packaging design as needed based on complexity.

• Understand considerations of complex packaging design and the interplay between product and package.

• Identify and mitigate risks through structural and materials design optimization.

• Collaborate with other engineers to influence the data-driven development of packaging systems for sterile and non-sterile products.

• Upskill fellow packaging engineers on risk-based experimental design and data analysis.

• Build inclusive, collaborative partnerships with internal and external stakeholders.

• Display ownership and proactively identify opportunities to build technical rigor into standard work and packaging platforms.

• Drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups.

• Navigate complex situations in a fast-paced environment while aligning packaging with product and patient needs.

Education Requirements:

• Bachelors degree (B.S./B.A) 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; OR

• PhD in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with five (5) years of relevant pharmaceutical development experience.

Required Experience and Skills:

• Large molecule autoinjector design experience

• End-to-End experience in packaging of pharmaceutical and/or medical device/combination products.

• Knowledge of current US and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging.

• Experience with a variety of primary, secondary, and tertiary packaging types common in the biopharmaceutical industry.

• Use of design and modeling tools to enhance understanding of distribution stresses and packaging dynamics.

• Ability to determine interrogate the science, identify true requirements, and proactively detect critical flaws.

• Leadership skills to enable collaboration with diverse business partners.

• Ability to drive complex projects to completion in a fast-paced environment.

• Ability to navigate ambiguity, embrace experimentation and learning, and model a growth mindset.

• Ability to identify technical capability gaps and influence other engineers.

• Excellent technical written and oral communication skills.

• Proficient in problem solving, risk-based decision-making, and use of standard work.

• Ability to maintain subject matter expertise and help the organization grow and learn in packaging development.

Preferred Experience and Skills:

• Background in application of numerical design and modeling tools.

• Quality by Design (QbD) experience.

• Experience in defining standard work processes and documents.

• Experience specifying, processing, and characterizing packaging materials.

• Expertise in hypothesis development and testing, statistical analysis, and Design of Experiments.

• Lean Six Sigma or Design for Six Sigma certification.

This document contains AI-generated content.

Required Skills:

Biologics, Combination Products, Compliance Packaging, Engineering Standards, Good Manufacturing Practices (GMP), Injection Devices, Leadership, Manufacturing Scale-Up, Packaging Engineering, Process Optimization, Root Cause Analysis (RCA), Technical Leadership

Preferred Skills: