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

MSD•Rahway, PA

9d•Hybrid

About The Position

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. The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Associate Director of MDCP Platform Packaging and Assembly Technical Leadership is integral to this mission. The successful candidate will possess deep technical expertise in assembly and packaging of MDCP, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape the technical capabilities and strategic direction for a global, cross-modality technical team. As an individual contributor, the associate director will lead cross functional teams. The leader will be responsible for executing the organization's priorities and ensuring the successful completion of projects. This includes the development and execution of robust technical plans across device assembly, packaging, and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images and packaging and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external networks The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, device development and technology teams, supply chain, operations, quality, analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed cost/benefit decisions based on the analysis of inputs, outcomes, risks, and company-wide prioritization.

Requirements

Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience 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 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 pharmaceutical packaging, combination product assembly and packaging, or related technical fields
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 an ability to determine interrogate the science, identify true requirements, and detect critical flaws including the ability to determine areas of potential risk, generate gap analysis 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.

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 the 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.