Merck Associate Director- Combination Products in Kenilworth, New Jersey
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director of Engineering, Medical Device and Combination Products (MDCP) is a key member of the MDCP technical Operations with responsibilities to provide technology stewardship to parenteral and Women Health combination products in the commercial space. Functioning within Global Phamaceuticals Operations Science & Technology, the Associate Director of Engineering will provide the technical leadership to execute reactive and proactive business critical programs. She or he shall also provide general scientific and engineering direction. The incumbent must demonstrate advanced knowledge, skills and abilities to create and optimize business, technical, and compliance processes. The person in this position participates in high impact, complex, cross-functional and cross-divisional teams and initiatives. Effective collaboration with teams is essential to meet Merck's goals/objectives. Prior experience in successfully managing and executing complex technical projects within parenteral products is highly desired.
She or he will be expected to function as an independent contributor, supporting complex global and site projects, including those related to Combination Products and Drug Delivery Systems, in a compliant manner. This includes leading, enabling or consulting in the development and execution of related strategic plans for problem-solving and continuous improvement by working with internal and external partners. The key stakeholders include Merck Manufacturing Division sites, External manufacturing, R&D, Quality, Operations, Product Development groups, Regulatory Affairs, Procurement and suppliers. Expertise in design control, medical device, combination products, material science, glass syringe manufacturing, polymer processing, pharmaceutical packaging and related scientific/technical concepts and techniques are a must for this position. The ability to apply these in a fast-paced operating environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The incumbent will routinely face competing priorities, and must manage time effectively, while keeping stake-holders and team members informed with effective communication.
Understanding the big picture, and how activities link to Merck strategy and business goals.
Utilizing design control expertise to develop value-add solutions to customer needs in medical devices and combination products
Securing early sponsorship and stakeholder alignment for projects and initiatives.
Operating effectively as a leader in assigned roles on projects, or as MDCP technical operations representative on multiple teams.
Displaying ownership and making informed cost/ benefit decisions based on analysis of inputs, outcomes,risks and likely return.
Demonstrating the necessary Inclusion skills to integrate inputs and perspectives from various sources, and communicates the decision and its Risk/Benefit implications to key stakeholders and sponsors.
Soliciting feedback to ensure that customer/stakeholder needs are the cornerstone of his/her decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems.
Actively supporting and applying the various initiatives and goals of MMD and the company.
Acting as a catalyst for change
Contributing to developing technical skills in the organization and building high performance teams.
Presenting effectively to both internal and external audiences to influence change and build consensus.
Providing candid, timely and tactful communication and feedback to team and collaborators.
Demonstrating Merck Leadership Behaviors and sets an example for the team.
Continuously undertakes professional development activities to improve skills
Education Minimum Requirement:
Required: A Bachelor's degree in Science or Engineering
Preferred: Master's degree or Ph.D. in Mechanical Engineering, Biomedical Engineering, Polymer or Plastic Engineering or similar
Required Experience and Skills:
A minimum of eight (8) years of experience with medical device or combination product commercialization, operations support, and materials/components.
Experience in the regulations of major markets in the medical device or Pharmaceutical industry, e.g. USFDA cGMPs, EMA.
Direct Experience in lifecycle management of combination products in glass prefilled syringes, parenteral manufacturing and complaint investigations etc.
Experience in plastics injection molding, and polymer processing.
Subject matter expertise in design controls, deviation management, change control, risk management and the fundamentals of documentation structure/ systems.
Proficiency in project management, from conception and initiation, through close-out.
The ability to apply the above competencies in a manner that challenges and enhances overall operational effectiveness and routinely provides feedback and coaching to team members and collaborators on these skills
The ability to complete all activities with the highest regard for all Merck divisional and local site procedures for safety, quality, and regulatory compliance.
Experience providing technical leadership to medical device and combination product manufacturing sites and functional areas, including the preparation of official documents
Preferred Experience and Skills: .
Experience in design control, risk analysis and change control management for medical device or combination products
Experience with pen injectors or auto injectors
Familiarity & comfort in working in a matrixed environment.
Understanding of Device design fundamentals (Tolerance Stacks, GD&T, Modeling in FEA/MathCAD/Simulink, Prototyping)
Lean Six Sigma Green Belt or higher certification
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job Packaging Engineering
Other Locations: NA-US-PA-West Point
Title: Associate Director- Combination Products
Primary Location: NA-US-NJ-Kenilworth
Requisition ID: PAC000334
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