Clinical Laboratory Scientist, Medical Affairs
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).
The successful candidate is responsible for the testing and development of proficiency testing material for Cepheid assays, laboratory work in the investigation of discrepant results reported by customers or end-users, laboratory accreditation assistance, and laboratory maintenance & management.
ESSENTIAL JOB RESPONSIBILITIES:
- Coordinates proficiency testing activities including ordering, testing, result submission, and reporting to internal departments
- Participates in NPI activities as needed to develop proficiency testing for new assays
- Performs compatibility testing of Cepheid products with proficiency testing available in the market
- Performs various technical laboratory procedures for the purposes of troubleshooting or investigating cases
- Assesses and obtains other laboratory services as required for complex laboratory testing
- Provides reports needed for the closure of cases
- Maintains and manages laboratory spaces including inventory of reagents and consumables, periodic maintenance, and other preventive maintenance on instruments as required
- Collaborates with cross-functional teams such as Medical Affairs, Scientific Affairs, Technical Support, Global Product Support, Post-Market Quality, etc. as needed for troubleshooting or investigating cases regarding specimens and clinical results
- Provides support for laboratory accreditation inquiries pertaining to the use of Cepheid products for diagnostic use
- Provides accurate clinical and technical information for products to support their use
- Identifies, supports, and coordinates process improvement opportunities from customer feedback
- Authors, updates, and curates knowledge base articles to support regional Technical Support centers as appropriate
- Maintains expertise through continuing education including but not limited to clinical trends, products, regulations, and products
- Establish, monitor, and report on process metrics with regards to timeliness, quality, first pass yield, etc.
- Collaborates with internal teams as necessary to perform duties
- Develops and delivers training for staff elements within job scope as necessary
Education or Experience (in years):
- Bachelor’s or Master’s degree in Life Science or Clinical/Medical Laboratory Science from an accredited university
- 5+ years’ experience in high complexity Clinical Microbiology specimen processing and laboratory techniques
- Licensed CLS or MLS by a recognized accrediting agency (ASCP, AMT, CA LFS)
Knowledge and skills:
- Working knowledge of Cepheid product lines
- Good understanding and ability to follow complex procedures and processes
- Strong proficiency in audit or laboratory inspection readiness
- Strong proficiency in documentation, preparation, and write-up of responses relating to laboratory accreditation inspections and audits
- Advanced knowledge and application of commercial computer application packages such as MS Office, web browsers, etc.
- Excellent written and verbal communication skills
- Outstanding troubleshooting and problem-solving skills
- Thrives in a dynamic, fast-paced, and constantly changing environment
- Self-motivated, organized, and possess strong attention to detail
- Flexible to work weekends and holidays if necessary
- Extended computer-telephone interactive tasks and/or prolonged static postures
- Lifting of objects up to 25 lbs. (equivalent to one full banker’s box)
- Manipulating specimens or samples containing bloodborne pathogens, latex particles, or other chemicals
- Possible exposure to ultraviolet light or lasers
- Extended periods of donning personal protective equipment including but not limited to lab coats, goggles, gloves, masks, etc.
- May travel up to 10%, domestic or international as required
PREFERRED REQUIREMENTS (optional):
- Knowledge and successful application of DBS (Danaher Business System) or Kaizen in problem-solving and continuous improvement
- Knowledge of FDA and ISO requirements, including Adverse Event Reporting
- Knowledge of HIPAA and other associated policies
- Knowledge of Salesforce CRM and Analytics
- Fluent in other languages
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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.