J&J Family of Companies Engineering Manager, Combination Product Development in Lexington, Massachusetts
Engineering Manager, Combination Product Development - 2306154052W
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Engineering Manager, Combination Product Development located in Lexington, MA.
At Janssen, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com
The Engineering Manager will be a leader in the development of new and innovative technologies, processes, solutions, and products. This position functions primarily in the development of combination products and will be part of a high caliber multi-functional team developing and driving innovative approaches that solve problems. Perform high level research and development supporting the implementation of new and existing technologies and processes. Designs experiments to statistically analyze and verify these technologies and processes and translation to combination product verification and validation. This role is part of the global Primary Container & Device (PC&D) Team.
The Engineering Manager will work closely with various Janssen Supply Chain (JSC) and Discovery, Product Development & Supply (DPDS) departments as part of a cross-functional CMC development team in support of developing new oncology therapies to determine unmet needs and provide potential solution and support existing innovation activities. Test these solutions and evaluate their value to our patients, care givers or healthcare providers.
Develop support strategy for programs or platforms with key business partners in support of the analysis of highly complex issues in a technical area and establishes resolutions/decision points in a given program/project.
Direct people management responsibility internally and external resources to develop, test and manufacture devices/combination products.
Establish plans for talent development, diversification, and professional development for employees.
Provides input on hiring, promotions, and other people-related decisions for teams/ work groups within the department
Participates/leads communities of practice providing expertise in specific engineering areas
Functions as engineering SME in single or multiple engineering topic(s).
Supports the development and validation of departmental, project and program budgets and goals.
Works with greater autonomy for longer term strategic initiatives establishing deliverables and organizational outcomes.
Identifies novel scenarios and nascent engineering/technically innovative opportunities in a specific engineering area. Develop IP as needed for programs or platforms
Establish external partnerships and collaborations with vendors and SMEs to advance specific projects.
Performs a high degree of independent judgment and execution which delivers on components of the strategic plan as assigned or directed by leadership.
Communicates overall strategy of the projects and initiatives to other stakeholder, both internally and externally.
Seeks to contribute to improving business/work processes to identify and enable the organization to cultivate new technical insights.
Ensures that all necessary procedures are followed with the product development process
May act as the senior author in the preparation of presentations, patents, scientific publications and journals.
May present data and recommendations to outside consultants, at in-house research forums and at outside professional meetings.
Lead small investigatory projects with cross-matrixed team members to evaluate new or existing technologies and/or processes. Ensure deliverables are met within scope, time and budget.
Collects and collates results and inferences and reports to project team and senior colleagues.
A minimum of a Bachelors degree in an appropriate Engineering discipline required
A minimum of 6 - 8 years’ relevant experience required
Experience with combination products and related regulations preferred
Project management skills is highly preferred
Advanced knowledge of statistics is preferred
Strong understanding of Good Manufacturing Practices (GMP) is highly preferred
Previous people leadership in a matrixed environment including mentoring, coaching & motivating is highly preferred
Strong stakeholder management and negotiation skills when working with internal and external partners required
Excellent verbal and written communications skills, with technical or multi-functional audiences required
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location NA-US-Massachusetts-Lexington
Organization Janssen Research & Development, LLC (6084)
Job Function Mechanical Engineering
Req ID: 2306154052W
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