Job Description Summary

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 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. 

JOB SUMMARY

In-depth knowledge of product development, extensive experience in scale up, process improvements, and transfer of production processes to Operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment in determining the scope and timing of transfer activities.   Represents reagent operations as a core team member in new product teams responsible for the development, scale up, validation and transfer of production processes to Operations. Works with cross functional teams and exercises judgment in determining the scope and timing of transfer activities. Responsible for improving process efficiency and product quality. May determine methods and procedures on new assignments, and may provide guidance to other lower level associates.

DUTIES AND RESPONSIBILITIES

1.   Represents Reagent operations in new product teams as the core team member.

2.   With minimal supervision and assistance, transfers products and processes into manufacturing following the Global Product Development System. 

a.   Develops strategies and executes plans to stabilize and reduce production cost of new products

b.   Develop, scale up and setup the manufacturing processes.

b.   Generates manufacturing plan based on the product requirements and the anticipated manufacturing resources needed to produce and ship the new product.

c.   Prepares and submits SOP’s, WI’s, BOM’s, routings and standard costing for new product into SAP

3.   Evaluate product history, recommend revisions to product specifications, originate Change Orders (CO's)

4.   Extensive knowledge in product lines or manufacturing processes.

5.   Responsible for working with the team to design, write and execute Gage R&R, scale up, stability, and validation studies and associated reports.

6.   With support from functional manager, interfaces with Product Development, Research, Quality, Regulatory and Production to bring new technologies, methods, and tests into Manufacturing

7.   Assists in the evaluation of technologies and processes for reliability, production capability, consistency, and cost effectiveness. Makes recommendations for process improvements.

8.   Assists and mentors fellow associates to develop skills and techniques

9.   Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management

10.    Coordinate the interactions between Manufacturing, QC, Sustaining, R&D, and QA to ensure on time execution to the project, identify and work through barriers that hinder progress. 

11.    Work with Subject Matter Experts to troubleshoot, identify,  and resolve issues in the manufacturing process. 

12.    Coordinate and carry out necessary documentation, training, qualification, and validation activities to support new or modified process changes or deviations.

13.    Engage leadership and stakeholders to obtain support and buy in for changes.

14.    Responsible for accurately assessing necessary changes within a product line to determine impacted components within an ACR.   

Education and Experience:

• Requires a minimum of a Bachelor degree with 7 years of experience or a Master’s degree with 5 years of experience or PhD with 2 years of Industry experience in biological sciences or related field

• A minimum of 6 years of experience in FDA or ISO regulated production environment

• A minimum of 1 years of experience in managing a large or complex project

• Project management experience

• Experience in SAP/ related Enterprise management system.

Assets

• Knowledge in antibody techniques, molecular biology techniques, instrumentation, and assays performed

• Knowledge of general laboratory safety, GMP's and associated regulatory requirements

• Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

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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.

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