Staff, Logistics Cold Chain Compliance in Brea, California at Beckman Coulter Diagnostics

Date Posted: 3/14/2018

Job Snapshot

Job Description

Job ID: BEC008607

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.

Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.

If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at

Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


The Staff, Logistics Cold Chain Compliance leader reports to the Senior manager of Logistics. The focus is on developing secondary packaging systems, establishing contract packaging organizations (CPOs), and qualifying cold-chain shipping solutions. Will work closely with Global Supply Chain, QA/QC, Technical Development, Regulatory Affairs to implement new processes and manage changes. This position participates in the development of a product delivery system to support a medical device diagnostics network. The candidate is accountable for the implementation, sustainment, improvement, and expansion of business solutions in areas of their responsibility.


• Business process owner for product delivery system solution. Partners closely with vendor and business partners developing and expanding solution as required.

• Develops and presents business cases for new capability.

• Serves as the business lead for cold chain solution development, implementation, and ongoing key performance management.

• Interacts with government agencies in the logistics areas to determine the most efficient and effective processes for cold chain management, import/export, chain of                    identity, chain of custody.

• Partners with Quality, Regulatory and Process Development to develop compliant business system solutions.

• Acts as the business lead for future implementations and expansions. Develops project plan, change management strategy, communication plans, testing                 requirements, training strategy, documentation, etc.

• Leads development of user requirements and use cases.

• Performs impact assessment on new or changing capability, including impact to GxP, Chain of Identity/Chain of Custody, SOPs, Training, SOX, and Data Integrity.

• Collaborates with a variety of functional groups and leadership, including Manufacturing, Quality, Regulatory, Clinical Operations, Commercial, Product Sciences,                           Finance, and IT on process improvements and cross-functional impact assessments.

• Owns non-conformances, CAPAs, and change controls as needed.

• Partners with peers on implementation of super user strategy and capabilities for long-term sustainment and continuous improvement of core processes.

• Authors and/or revises Standard Operating Procedures and Work Instructions as required.

• Develops and delivers training.

• Responsibilities may include; development of program templates, test plans, testing, communication, audit, corrective actions, etc.

• Develop rigorous strategies to reduce costs and supply risk through disciplined analysis, analytics, trending and modeling of key operational data 

• Develops and presents business cases for new capability.

• Developing tools, processes, and criteria to evaluate supplier performance 

• Develop, specify and qualify cold-chain shipping solutions for passive and active shipping systems 

• Validating packaging operations 

Additional Functions And Responsibilities

• Demonstrates strong leadership and communication skills to work across functions and influence to facilitate execution of key projects and initiatives aligned with corporate vision.


Travel may be occasionally required (up to 15%).

Job Requirements


Position Requirements

• Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.

• Strong understanding of pharmaceutical and/or medical device supply chain.

• Knowledge of GxP’s, FDA guidelines, and other relevant international and domestic relations.

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

• Bachelor’s Degree required in business management/science/engineering. Advance degree a plus.

• Strong knowledge of GMP and Supply Chain systems and processes.

• Strong project/portfolio management skills.

• Strength in communicating and working independently and effectively with broad stakeholders in various scientific/technical/business disciplines.

• 5+ years of experience in an operations role in the medical devices industry or similar.

• Ability to collaborate and communicate with a variety of key stakeholders (IT, Finance, Manufacturing, Logistics, Quality, Supply Chain).

• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.

• Advanced Excel and PowerPoint skills.

• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.

• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

• Excellent communication skills, including presentation and influence with all levels of staff, including executives.

• Role model for Beckman Coulter values

• Experience qualifying cold-chain shipping containers 

Education And Professional Experience

• Bachelors Degree preferred, in related field from an accredited college or university.

• 5 years of related pharmaceutical, medical device industry. (Equivalent combination of experience and education may be considered.)

• Proven success in project management in the pharmaceutical or medical device industry.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.