Merck
Associate Director, Engineering- Packaging Commercialization
Merck, West Point, Pennsylvania, us, 19486
Associate Director, Engineering- Packaging Commercialization
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Associate Director, Engineering- Packaging Commercialization
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Merck Job Description
The Associate Director, Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products including small molecules, biologics, vaccines and oral solid dosage. This role involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and execution of overall packaging strategies that meet global network needs. Responsibilities include ensuring packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs. Minimum Education Requirement And Experience
Bachelor (BS/BA) 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
Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components Demonstrated understanding of Medical Device and Combination Product regulations 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 Preferred Experience And Skills
Medical Device and Combination Product Packaging development experience Quality by Design (QbD) experience Experience in defining standard work processes and documents Experience specifying, processing and characterizing packaging materials including rigid and flexible barriers, pulp/paperboard and recyclables EEO Statement
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
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Join to apply for the
Associate Director, Engineering- Packaging Commercialization
role at
Merck Job Description
The Associate Director, Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products including small molecules, biologics, vaccines and oral solid dosage. This role involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging as well as prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and execution of overall packaging strategies that meet global network needs. Responsibilities include ensuring packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs. Minimum Education Requirement And Experience
Bachelor (BS/BA) 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
Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components Demonstrated understanding of Medical Device and Combination Product regulations 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 Preferred Experience And Skills
Medical Device and Combination Product Packaging development experience Quality by Design (QbD) experience Experience in defining standard work processes and documents Experience specifying, processing and characterizing packaging materials including rigid and flexible barriers, pulp/paperboard and recyclables EEO Statement
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
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