Overview
Director, Engineering Assembly and Packaging Platform Technical Leadership role at Merck. Reporting into the Executive Director Packaging Technical Operations; responsible for technical leadership, strategic planning and portfolio execution of key packaging and assembly platforms, focusing on combination drug products such as prefilled syringes and autoinjectors.
Responsibilities
- Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement.
- Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence across the assembly and packaging platform portfolio, including safety, efficacy, quality, and robust supply standards for platforms (e.g., syringes, auto injectors, bottles, blisters).
- Drive proactive risk management activities, including risk assessment, mitigation, and communication.
- Develop and maintain relationships with internal stakeholders to facilitate effective technical support and platform stewardship, including above-site support for investigations, complaints monitoring and rapid response.
- Develop and maintain KPIs; manage the platform portfolio and ensure delivery on priorities.
- Provide strategic leadership for technical support for the platform stewardship team, including tech transfers and lifecycle management; establish platform standards.
- Provide technical guidance for lifecycle changes for packaging platforms and ensure regulatory filings; ensure thorough engineering and packaging science applied to deliverables for new product introductions and tech transfers.
Minimum Education Requirements And Experience
BS in packaging / mechanical / chemical / biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience; ORMS in packaging / mechanical / chemical / biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience; ORPhD in packaging / mechanical / chemical / biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experienceRequired 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 qualification and validation, design controls and risk management.Leadership experience; managing technical teams supporting packaging and combination product assembly & packaging.Strong problem-solving and decision-making; ability to analyze inputs, identify requirements, and mitigate risks.Knowledge of global regulatory requirements for medical devices and combination products and packaging.Understanding of risk management principles (ISO 14971).Strategic and analytical thinking; continuous improvement and best practices.Excellent communication and interpersonal skills with stakeholders.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants, and prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about rights under US EEO laws, visit : EEOC Know Your Rights, EEOC GINA Supplement.
Additional Information
US and Puerto Rico Residents Only; accommodation during the application or hiring process.Hybrid work model in U.S. with three on-site days per week; some roles remote.Salary range : $153,800.00 - $242,200.00; eligible for annual bonus and long-term incentives where applicable.Benefits include medical / dental / vision, retirement, paid holidays, vacation, and more; details at Merck compensation and benefits.Application links and deadlines are on merck.com.Job Details
Seniority level : DirectorEmployment type : Full-timeJob function : Engineering and Information TechnologyIndustries : Pharmaceutical ManufacturingTravel : 10%J-18808-Ljbffr