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Manager, Development in Sunnyvale, California at Cepheid

Date Posted: 1/11/2019

Job Snapshot

Job Description

Job ID: CEP002535

About Us

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).


Description

  • Job Title: Development Manager-FIT Program

    POSITION SUMMARY:

    This position is part of the FIT (FAST IMPACT TEAM) in the Biotechnology R&D department. The development manager will function as the R&D technical lead for the core team comprised of cross-functional department members.
    The FIT Program objective is to dedicate highly skilled cross-functional teams to product Sustaining and product Enhancement projects. R&D FIT will support 2-4 prioritized projects simultaneously based on customer and/or business impact.

    This position will include management of 2 scientist-level direct reports.

    The candidate will plan experimental, analytical, stability and/or robustness studies required to demonstrate appropriate project objectives. Project scope will include opportunities for cost savings and process improvements. The ability to apply skills in scientific creativity and collaboration with cross-functional departments is highly desirable for fast impact and on-time completion of deliverables. In addition to technical qualifications, the ideal candidate will be highly goal-oriented, organized and able to thrive in an atmosphere of shifting demands and priorities.

    The candidate should possess excellent oral and written communication skills with the ability to recognize the need for escalation to upper management and/or stakeholders. The ideal candidate will be able to clearly and comfortably delegate both routine and important tasks and decisions.

    As the technical lead and R&D subject matter expert the Development Manager will be instrumental in defining project scope, goals and deliverables.

    The candidate must have experience with Design Control and Product Development Processes. Due to the challenges of broad range of the FIT Program objectives, the preferred candidate will also have extensive knowledge of the Cepheid product menu, the GeneXpert platform and Cepheid manufacturing processes.
  • Job Description

    ESSENTIAL JOB RESPONSIBILITIES:

    • Define project tasks and resource requirements.
    • Help develop strategies for development of complex in vitro diagnostic tests for Enhancement projects.
    • Help develop and write verification and validation SOPs and technical reports.
    • Track project technical project deliverables using appropriate tools.
    • Provide direction and support to internal technical team and cross-functional core teams.
    • Constantly monitor and report on progress, problems and solutions to upper management.
    • Present data at technical meetings.
    • Present data at Executive meeting or deep-dive report-outs.
    • Demonstrated ability to apply analytical problem solving skills to reagent and system integration issues to identify critical performance factors.
    • Demonstrated ability to apply analytical problem solving skills to processes to identify critical performance factors.
    • Allocate time and resources efficiently, effectively prioritize, and continually seek innovative ways to meet individual, team and corporate goals.
    • Be highly goal-oriented and organized with the ability to adapt and thrive in an atmosphere of shifting demands and priorities.

Job Requirements



Qualifications

MINIMUM REQUIREMENTS:

Education or Experience (in years): 

  • BS with 9+ years or MS with 7+ years of experience, or PhD with 1 to 2 years of experience at a molecular diagnostics company, public health laboratory or similar institution. Experience in developing molecular diagnostic assay products in micro-fluidic assay platforms similar to the GeneXpert is highly desirable. Expert level knowledge of design control and product development processes is required.

Qualifications: 

  • Proven understanding of assay product development life-cycle.
  • Proven experience in Quality System Regulations (QRS) 21 CFR 820; Design Control ISO:13485:2003.
  • Proven experience in launching multiple products from concept to commercialization stage.
  • Proven experience in people management
  • Working knowledge of quality documentation management systems.
  • Experience working with microorganisms involved in infectious diseases.
  • Experienced in interpreting and analyzing large scale experimental data sets.
  • Real time PCR or RT-PCR and product development experience.
  • Strong problem-solving/troubleshooting skills that can translate to direct guidance of team members through complex issues.
  • Excellent documentation and communications skills.
  • Proficiency with standard Microsoft computer programs.
  • Experience with design of experiments (DOE) methods desirable.

Preferred Qualifications: 

  • Medical device and/or in vitro Diagnostic product launch experience is highly preferred.
  • 15+ years of work experience in biology, chemistry or related fields.
  • Real time PCR or RT-PCR and product development experience.

Physical requirements/abilities: 

  • Ability to work in an office environment


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.