Job Description Summary

Job Description

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We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Our vision for “function or BU” at BD

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About the role:

• Serves as a key customer facing ZebraSci NJ operations contact, communicates project updates to customers & internal senior leadership, builds robust customer relationships, and ensures projects are completed in accordance with customer expectations and company’s standard operating procedures.
• Develops and maintains a working knowledge of commonly prescribed methods, background information, and combination product testing strategies.
• Manages the NJ operations staff and site-wide operations activities to prioritize projects, resources, and equipment.
• Oversees the day-to-day workload, timelines, onboarding and delivery of customer projects.
• Directly manages the Lab Supervisor, Lead Technician(s), and additional operations engineer/scientist technicians, as needed
• Sets goals and provides career support, guidance, mentorship, and development opportunities for operations staff
• Conducts regular 1:1 to set performance expectations and track performance of operations staff
• Conducts performance reviews (as set by company policy)
• Trains personnel in company policies, quality system, and procedures
• Participates in development and maintenance of the company’s training programs in compliance to cGMP and/or ISO guidelines
• Assists in hiring, training and supervising of contractors, and Quality Assurance personnel as required

Key responsibilities will include:

• Continuously collect market intelligence by analyzing industry, public policy, and social trends to identify new market requirements, customer attitudes, demands, behaviors, and unmet customer needs.
• Collaborates with commercial and technical development personnel to support the development of proposals & service solutions for customers.
• Collaborates with technical development team to implement new methods and processes to support customer needs.

Responsible for site performance and capabilities development:

• Accountable for NJ site execution performance
• Manages and communicates NJ site progress and operations capacity during weekly sales and operations planning meetings
• Manages revenue recognition and milestone completion with finance staff
• Communicates to appropriate finance team(s) when invoicing milestones have been met

About you:

• Oversees the handling and resolution of quality events such as non-conformances, deviations, and CAPAs, and updates Quality System documents while ensuring cross-site alignment.
• Leads workstreams to think critically, analyze problems, identify solutions, and implement recommendations to manage quality events in collaboration with quality team.
• Works with Laboratory Supervisor to review and prioritize the delivery of protocols and reports as required
• Edits, authors, and reviews SOPs, IQ/OQ/PQ, change control & other technical documentation related to ZebraSci processes and services as needed.
• Ensures that company standard operating procedures are being followed and that customer expectations are met
• Coordinates directly with ZebraSci California and Becton Dickinson services groups to ensure the delivery of customer work by leveraging cross-site capabilities, systems, and procedure.

Education and experience required:

• Knowledge of drug-device combination products and/or medical devices including market available technologies from major industry suppliers
• Superior communication skills, both written and oral
• Attention to detail with demonstrated ability to multi-task in a fast-paced environment, manage changing priorities, and communicate effectively across the organization
• Advanced project and time management skills; skilled in driving operations
• Ability to delegate effectively
• Strong leadership skills.
• Strong technical writing skills.
• Familiarity with ISO, ICH, ASTM standards is preferred
• Familiarity with combination products development and marketed / pipeline devices is preferred
• Bachelor’s Degree in science or engineering field. Master’s degree is a plus.
• 4+ years of experience in pharmaceutical, device, or contract research and development industry (or adjacent field). Research or testing experience in a laboratory setting is required.
• Experience working within a GMP and/or highly regulated environment is preferred.
• People management experience is preferred.
• Customer management and relationship building experience is preferred.
• Experience working within a cGMP environment is preferred

Click on Apply if this sounds like you!

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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