Merck · 17 hours ago
Associate Director, Engineering
Lansdale, PA
Full-time
Hybrid
Lead/Staff, Director/Executive
$129K/yr - $203K/yr
5+ years expMerck is dedicated to advancing the prevention and treatment of diseases in people and animals through innovative health solutions. They are seeking a passionate and experienced Associate Director of Engineering to contribute to the development of cutting-edge biologic and vaccine drug substances, drug products, and medical device combination products.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
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
Qualification
Required
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
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
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
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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