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Assoc. Dir., Engineering, Combination Products Platform Assembly and Packaging Technical Leadership
Assoc. Dir., Engineering, Combination Products Platform Assembly and Packaging Technical LeadershipMerck • West Point, AL, US
Assoc. Dir., Engineering, Combination Products Platform Assembly and Packaging Technical Leadership

Assoc. Dir., Engineering, Combination Products Platform Assembly and Packaging Technical Leadership

Merck • West Point, AL, US
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Overview

Assoc. Dir., Engineering, Combination Products Platform Assembly and Packaging Technical Leadership at Merck. Reporting into the Director Packaging Platform Technical Leadership, the Associate Director Medical Device and Combination Product (MDCP) Platform Packaging and Assembly Technical Leadership will be responsible and accountable for technical leadership, strategic planning and portfolio execution of key packaging and assembly platforms, with a focus on combination drug products such as prefilled syringes and autoinjectors.

Responsibilities

  • Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence across the MDCP assembly and packaging platform portfolio, including interrogation of data / science through technical reviews and exploring alternative ways to view and solve problems to achieve results.
  • Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
  • Collaborate with cross-functional teams to ensure that all platforms (e.g. syringes, auto injectors, kits) meet safety, efficacy, quality, and robust supply standards.
  • Develop and maintain strong relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders, and Value Chain to facilitate effective technical support and platform stewardship. This includes above-site support for significant investigations, complaints monitoring and rapid response activities.
  • Manage the portfolio of work in the platform, holding the cross-functional team accountable to deliver on priorities.
  • Provide strategic leadership and direction for technical support and MDCP packaging & assembly platform stewardship, including managing ongoing changes and tech transfers for the components, equipment, and processes. Develop, maintain, and refine technical platform lifecycle management plans, setting and managing and optimizing platform standards.
  • Oversee lifecycle changes for MDCP packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards. Ensure thorough engineering, medical device and packaging science is applied to deliverables for new product introductions and tech transfers across the network inclusive of aligning the control and validation strategies.

Minimum Education Requirements And Experience

  • Bachelor of Science (BS) in packaging / mechanical / chemical / biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
  • Master of Science (MS) in packaging / mechanical / chemical / biochemical engineering, pharmaceutical science or chemistry or related fields with ten (10) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
  • PhD in packaging / mechanical / chemical / biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields
  • Required Skills And Experience

  • Subject matter expertise in medical device and combination product commercialization and tech transfer, assembly and packaging process improvement and support from early stage through launch and supply, including components, process, and equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification / validation.
  • Demonstrated experience in a leadership role; managing cross functional teams supporting medical device and / or combination product assembly and packaging.
  • Strong problem-solving and decision-making skills with the ability to interrogate the science, identify true requirements, and detect critical flaws including the ability to determine areas of potential risk, generate gap analyses and mitigation strategies.
  • In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging.
  • Strong understanding of risk management principles, including ISO 14971 and other relevant standards.
  • Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.
  • Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
  • Current Employees apply HERE

    Current Contingent Workers apply HERE

    US And Puerto Rico Residents Only

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

    Equal Employment Opportunity

    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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

    We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas come together in an inclusive environment.

    Additional Details

    Hybrid work model in the U.S. applies; salary range $126,500.00 - $199,100.00; bonus and long-term incentive eligibility; relocation domestic; travel up to 10%; job is full-time; no visa sponsorship.

    J-18808-Ljbffr

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    Platform Engineering • West Point, AL, US

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