BD
Site Services Director (ONSITE Tmecula, CA)
BD, Plainfield, Illinois, United States, 46768
Job Description Summary
This position is reporting to the Director of Combination Products and Technical Services.
As part of the ZebraSci Leadership Team, the Site Services Director is responsible for contributing to the business strategy, directing site technical and scientific activities related to combination product development services, leading all aspects of the Temecula, CA site operations for combination product testing, and ensuring that customer projects are executed efficiently, in compliance with requirements, and with a positive customer experience. S/he will be responsible for managing the site budget, making appropriate investments, and leading the site staff responsible for service delivery. The Site Services Director will serve as a primary contact for pharmaceutical customers and a main point of contact for site visits and audits by customers or regulatory authorities.
Job Description
We are
the makers of possibleBD 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.This position is reporting to the Director of Combination Products and Technical Services.As part of the ZebraSci Leadership Team, the Site Services Director is responsible for contributing to the business strategy, advising site technical and scientific activities related to combination product development services, leading all aspects of the Temecula, CA site operations for combination product testing, and ensuring that customer projects are executed efficiently, in compliance with requirements, and with a positive customer experience. They will be responsible for managing the site budget, making appropriate investments, and leading the site staff responsible for service delivery. The Site Services Director will serve as a primary contact for pharmaceutical customers and a main point of contact for site visits and audits by customers or regulatory authorities.PRIMARY DUTIES, RESPONSIBILITIES & AUTHORITIES :Serves as a combination products expert and leads customer engagement:Uses technical expertise to contribute to the customer sales process and services delivery, while maintaining a customer-focused outlook
Builds strong working relationships with customers to understand, on a deep level, the technical needs and issues and translates these into appropriate responses, solutions, services, and executable action plans
Educates and provides customer consultation on technical aspects of combination products and testing services, as appropriate
Manages, develops, and drives the Temecula, CA staff including:Supervises the onboarding, scheduling, and delivery of new customers and customer projects, while ensuring customer expectations are exceeded
Oversees day-to-day workload, priorities, and timelines
Sets goals and provides career support, guidance, mentorship and development
Conducts regular 1:1 and staff sessions for cross-functional feedback
Conducts performance reviews (as set by company policy)
Performs site succession planning
Demonstrates technical expertise to train and guide engineering/scientific staff on the development and execution of combination products testing services
Drives internal cross-functional team (business development, quality, service operations) collaboration to discuss and resolve challenges with service projects, provide updates, and ensure execution to plan
Participates in development and maintenance of the company’s training programs in compliance to cGMP and/or ISO guidelines.
Responsible for site maintenance, operating requirements, investments, and capabilities development:Responsible for leading all facilities work, leveraging site staff as appropriate
Identifies, builds, and maintains an external network of experts/companies to support capabilities development and deployment
Assists with site accreditations and renewals as needed
Participates, hosts, and conducts, internal, customer, and sub-contractor / supplier audits and visits, as needed
Manages the site budget and capital investments in conjunction with the Senior Leadership. Tracks and ensures operational efficiency and appropriate staffing of the site
Supports business development and captures and translates market insights to drive the business:Ensures site Technology Development team scouts new testing technology trends and stays abreast of changing regulations, standards, and environment relevant to combination products
Develops content for technical support, services, and customer experience/journey, as well as represents ZebraSci at major scientific conferences
Shares gathered intelligence and technical findings across ZebraSci team, BD network, and 3rd parties as appropriate
KNOWLEDGE AND SKILLS:Developed technological skills, including knowledge of drug-device combination products and/or medical devices including market available technologies from major industry suppliers, knowledge of the operation of mechanical measurement equipment (e.g. Instron, Zwick, etc.) and container closure integrity instrumentation, and experience with method validation and test protocol generation, execution, and reporting
Knowledge of small-scale filling and component assembly is desirable
Deep understanding of design control and system integration is desirable
Working knowledge of industry standards and requirements (ex. cGMP)
Application of statistical and analytical methods such as Design of Experiments, ANOVA analysis, and statistical software (Minitab, Jump, etc.)
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
Sophisticated project and time management skills; skilled in driving operations
Ability to delegate effectively
EDUCATION AND EXPERIENCE :BS (MS or PhD degree preferred in a science or engineering discipline) plus proven experience in medical device, IVD and/or pharmaceutical industry working with combination products
10+ years working in a technological or operational role within medical devices and/or pharma combination products with a BS (8+ for MS, 6+ for PhD)
People management experience
Experience working within a cGMP environment
Experience interacting with regulatory agencies and participating in or managing inspections
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 https://bd.com/careersBecton, 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 Our Commitment to You.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$147,200.00 - $242,900.00 USD Annual
This position is reporting to the Director of Combination Products and Technical Services.
As part of the ZebraSci Leadership Team, the Site Services Director is responsible for contributing to the business strategy, directing site technical and scientific activities related to combination product development services, leading all aspects of the Temecula, CA site operations for combination product testing, and ensuring that customer projects are executed efficiently, in compliance with requirements, and with a positive customer experience. S/he will be responsible for managing the site budget, making appropriate investments, and leading the site staff responsible for service delivery. The Site Services Director will serve as a primary contact for pharmaceutical customers and a main point of contact for site visits and audits by customers or regulatory authorities.
Job Description
We are
the makers of possibleBD 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.This position is reporting to the Director of Combination Products and Technical Services.As part of the ZebraSci Leadership Team, the Site Services Director is responsible for contributing to the business strategy, advising site technical and scientific activities related to combination product development services, leading all aspects of the Temecula, CA site operations for combination product testing, and ensuring that customer projects are executed efficiently, in compliance with requirements, and with a positive customer experience. They will be responsible for managing the site budget, making appropriate investments, and leading the site staff responsible for service delivery. The Site Services Director will serve as a primary contact for pharmaceutical customers and a main point of contact for site visits and audits by customers or regulatory authorities.PRIMARY DUTIES, RESPONSIBILITIES & AUTHORITIES :Serves as a combination products expert and leads customer engagement:Uses technical expertise to contribute to the customer sales process and services delivery, while maintaining a customer-focused outlook
Builds strong working relationships with customers to understand, on a deep level, the technical needs and issues and translates these into appropriate responses, solutions, services, and executable action plans
Educates and provides customer consultation on technical aspects of combination products and testing services, as appropriate
Manages, develops, and drives the Temecula, CA staff including:Supervises the onboarding, scheduling, and delivery of new customers and customer projects, while ensuring customer expectations are exceeded
Oversees day-to-day workload, priorities, and timelines
Sets goals and provides career support, guidance, mentorship and development
Conducts regular 1:1 and staff sessions for cross-functional feedback
Conducts performance reviews (as set by company policy)
Performs site succession planning
Demonstrates technical expertise to train and guide engineering/scientific staff on the development and execution of combination products testing services
Drives internal cross-functional team (business development, quality, service operations) collaboration to discuss and resolve challenges with service projects, provide updates, and ensure execution to plan
Participates in development and maintenance of the company’s training programs in compliance to cGMP and/or ISO guidelines.
Responsible for site maintenance, operating requirements, investments, and capabilities development:Responsible for leading all facilities work, leveraging site staff as appropriate
Identifies, builds, and maintains an external network of experts/companies to support capabilities development and deployment
Assists with site accreditations and renewals as needed
Participates, hosts, and conducts, internal, customer, and sub-contractor / supplier audits and visits, as needed
Manages the site budget and capital investments in conjunction with the Senior Leadership. Tracks and ensures operational efficiency and appropriate staffing of the site
Supports business development and captures and translates market insights to drive the business:Ensures site Technology Development team scouts new testing technology trends and stays abreast of changing regulations, standards, and environment relevant to combination products
Develops content for technical support, services, and customer experience/journey, as well as represents ZebraSci at major scientific conferences
Shares gathered intelligence and technical findings across ZebraSci team, BD network, and 3rd parties as appropriate
KNOWLEDGE AND SKILLS:Developed technological skills, including knowledge of drug-device combination products and/or medical devices including market available technologies from major industry suppliers, knowledge of the operation of mechanical measurement equipment (e.g. Instron, Zwick, etc.) and container closure integrity instrumentation, and experience with method validation and test protocol generation, execution, and reporting
Knowledge of small-scale filling and component assembly is desirable
Deep understanding of design control and system integration is desirable
Working knowledge of industry standards and requirements (ex. cGMP)
Application of statistical and analytical methods such as Design of Experiments, ANOVA analysis, and statistical software (Minitab, Jump, etc.)
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
Sophisticated project and time management skills; skilled in driving operations
Ability to delegate effectively
EDUCATION AND EXPERIENCE :BS (MS or PhD degree preferred in a science or engineering discipline) plus proven experience in medical device, IVD and/or pharmaceutical industry working with combination products
10+ years working in a technological or operational role within medical devices and/or pharma combination products with a BS (8+ for MS, 6+ for PhD)
People management experience
Experience working within a cGMP environment
Experience interacting with regulatory agencies and participating in or managing inspections
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 https://bd.com/careersBecton, 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 Our Commitment to You.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$147,200.00 - $242,900.00 USD Annual