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Sr Scientist, PCR Assay Development
Company: Cepheid
Location: Sunnyvale, CA
Employment Type: Full Time
Date Posted: 05/14/2021
Expire Date: 06/13/2021
Job Categories: Customer Service and Call Center, Healthcare, Other, Healthcare, Practitioner and Technician, Information Technology, Manufacturing and Production, Science, Research & Development, Medical, Environmental
Job Description
Sr Scientist, PCR Assay Development

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert System, weve 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).

Are you a senior level scientist with extensive experience in the development of molecular assays who is capable of delivering products for our Oncology program?

Cepheid, a Danaher company, is growing at a rapid rate and has a new opportunity for a Senior Scientist in Oncology for the site in Sunnyvale California.

The Senior Scientist, Oncology R&D, is a full-time position, working directly on product development in Cepheids Oncology program to deliver best in class Oncology assays!! The individual will lead R&D studies including design of statistically robust experiments for solid tumor assays, as well as support thorough documentation to meet QSR Design Control, and GLP/GMP requirements.

The successful candidate will be a highly motivated individual with scientific and technical proficiency in molecular biology techniques and statistics. A background in cancer biology is highly desirable. This is a rewarding opportunity to work at the cutting edge of molecular diagnostics and directly impact cancer patient management.

Essential job responsibilities:

Direct and mentor an Oncology R&D team focused broadly on solid tumor applications

Work collaboratively with Oncology R&D, Medical & Scientific Affairs and other functional department members to deliver best-in-class Oncology tests

Develop new and/or enhance existing Oncology IVD and custom real-time PCR assays following Cepheids Design and Development guidelines, including, but not limited to:

Providing data driven direction and guidance to Scientists and Research Associates.

Guiding team in a matrix environment and representing Oncology R&D on the Core team to collaborate with other functions (i.e., Product Transfer, Regulatory, Quality, Technical Support and Operations) to coordinate product development and improvement

Clinical trial planning and data reviews with Clinical Affairs necessary for Regulatory submissions.

Control Limit Setting, Test Method Validation planning and data reviews with Product Transfer and Biostats vital for defining product quality specifications.

Lead complex experimentation including data collection, summary and critical analysis to meet project, department and company objectives.

Use analytical techniques to characterize factors that influence product performance and conduct optimization studies to get to the optimal design.

Lead team in systematic problem analysis and resolution processes for project advancement. Anticipate potential problems with preventive solutions.

Apply creativity and innovation in designing products that are robust and manufacturable to meet customers needs.

Maintain a high level of professional expertise by keeping up with current scientific literature, challenging technologies and/or products

Maintain thorough documentation to meet QSR Design Control, as well as other international standards, such as ISO compliance and GLP/GMP requirements, etc.

Lead Oncology R&D staff, including hiring, training, performance management and development

Follow all company safety regulations and procedures. Ensure compliance of assigned staff.

TRAINING RESPONSIBILITIES: (REQUIRED)

Complete all assigned and required training satisfactorily and on time

Cepheids Hepatitis B vaccination policy requires that all personnel who work in BSL-2 labs to be vaccinated. Receiving the vaccine, or being vaccinated, is a condition of employment for new hires. Cepheids Hepatitis B vaccination policy requires that evidence of completion accompany the Hepatitis B Vaccine Notification form. Individuals are responsible for their personal medical records and it is expected that they will have access to these. If you cannot obtain the required documentation, Cepheid will authorize you to receive the vaccine. As for all unvaccinated associates, Cepheid will cover the vaccination expenses. Consistent with this policy, someone who is not vaccinated or cannot provide documentation of vaccination is not permitted lab access until they have received the first dose.

Minimum requirements:

Education and Experience (in years):

  • PhD with 5+ years and/or Masters degree with 8+ years and/or Bachelors degree with 10+ years experience in Biology, Biochemistry, Molecular Biology, Genetics, or the equivalent education are required.

Knowledge and skills:

  • Experience in the development of molecular assays with at least 6 years of experience in the Medical Device, Diagnostics or similar regulated industrial markets.
  • Highly proficient in gene expression assays and PCR assay development
  • Capable of estimating resource requirements to build and deliver products on aggressive timelines
  • Excellent working knowledge and experience in implementing and following robust design control processes for CE or US-IVD tests.
  • Excellent analytical abilities and thorough understanding of statistical methods used in development of molecular methods.
  • Persistent and flexible in response to change. Able to navigate through complexity

Physical requirements/abilities:

  • Be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.

Preferred requirements:

  • Ability to independently and strategically develop project proposals and plans.
  • Extensive assay development experience utilizing molecular technologies as well as sample processing techniques, including pre-analytical factors, for solid tumor assays
  • Experience planning, directing and executing development of products to meet CE-IVD, FDA (510(k) and/or PMA), and other regulatory agency requirements on aggressive timelines.

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.

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Company Name: Cepheid
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Website: https://jobs.danaher.com/global/en/...
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