Combination Product Service Operations Manager (Onsite/Temecula, CA)

Job Description Summary

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The ZebraSci Services Operations Manager will work with pharmaceutical and biotechnology companies to accelerate their combination product development program with ZebraSci services.

The Services Operations Manager will oversee the on-time completion of client projects / project deliverables, manage engineering technician staff, and ensure that projects are completed in alignment with the ZebraSci GMP quality system. All projects and services will comply with client requirements, the company's standard operating procedures, and regulatory agencies regulations.

Job Description

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 o ur 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.

PRIMARY DUTIES, RESPONSIBILITIES & AUTHORITIES:

Lead and manage the site engineering technician staff and project priorities. Oversee client projects, communicate project updates to clients/management, and ensure projects are completed in accordance with client expectations and company's standard operating procedures. Collaborate with commercial and technical personnel to support the development of proposals/solutions for clients Motivate team, set performance expectations, track performance, provide staff with timely feedback, and report metrics to management as required. Service operation management conducts, performs and/or ensures the following:

• Works with engineering technician staff to author test protocols as required
• Oversees laboratory data and document review to ensure work is completed in alignment with company procedures and client expectations.
• Authors and reviews test reports as needed.
• As needed, edit, author SOPs, IQ/OQ/PQ, change control & other technical documentation related to ZebraSci processes and services.
• Manage equipment and staff schedules to maximize efficiency and productivity.
• Operations Capacity planning and Lab facility management
• Ensures that company standard operating procedures are being followed.
• Collaborate with the technical development team to implement new methods and processes to support client projects.
• Analyze problems, identify solutions, and implement recommendations as well as manage quality events in collaboration with the quality team.
• Oversee and assist with equipment maintenance schedule including instrument calibrations, performance verification, and IQOQPQ.
• Assist with quality system-related tasks including but not limited to handling and resolution of quality events such as non-conformances, deviations, and CAPAs, including updates to Quality System documents as needed.
• Train personnel in company policies, quality system, and procedures.
• Maintain a working knowledge of commonly prescribed methods, background information, and troubleshooting strategies. Support client and agency audits and inspections
• Other activities and duties as needed or assigned

Education, Experience and Skills:

• Experience in the pharmaceutical, combination product, or pharmaceutical services industry
• Experience in laboratory operations or batch production-level Project management and PMP certification is preferred.
• Demonstrates excellent interpersonal skills, solid organizational / prioritization skills and a passion for providing excellent service.
• Flexibility and ability to multitask; can work within a fast-moving environment with multiple shifting priorities and demonstrate resourcefulness in setting priorities and guiding investment in people and systems
• Candidate must be a self-starter that can tackle new challenges that may not have known outcomes while also driving toward clarity and solutions
• Knowledge and experience with common prescribed methods such as USP, ISO and ASTM procedures

EDUCATION AND EXPERIENCE:

• Bachelor's, Master's or PhD degree in a science or engineering discipline plus relevant experience related to combination product or medical device manufacturing/production and/or testing:
  
  • 1-3 years of experience with a PhD
  • 3-5 years of experience with a MS
  • 5-10 years with a BS

Position is ONSITE in Temecula, CA. Ideal candidate will be in Temecula area or willing to relocate.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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.

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

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.

Primary Work Location

USA CA Temecula

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under .

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information
$124,100.00 - $204,800.00 USD Annual

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