Staff Scientist, R&D MEMP
Company: Futureshaper.com
Location: Sunnyvale
Posted on: May 4, 2025
Job Description:
At Cepheid, we are passionate about improving health care
through fast, accurate diagnostic testing. Our mission drives us,
every moment of every day, as we develop scalable, groundbreaking
solutions to solve the world's most complex health challenges. Our
associates are involved in every stage of molecular diagnostics,
from ideation to development and delivery of testing advancements
that improve patient outcomes across a range of settings. As a
member of our team, you can make an immediate, measurable impact on
a global scale, within an environment that fosters career growth
and development.Cepheid is proud to work alongside a community of
six fellow Danaher Diagnostics companies. Together, we're working
at the pace of change on diagnostic tools that address the world's
biggest health challenges, driven by knowing that behind every test
there is a patient waiting.Learn about the which makes everything
possible.The Staff Scientist, R&D MEMP is responsible for
planning, executing, and discussing experiments that drive product
development and sustainment. As a Staff Scientist, R&D MEMP the
employee has opportunities to learn Cepheid integrated platforms
and technology with the goal of developing infectious disease tests
that Cepheid has planned in its product pipeline. These activities
are in support of new product development (NPD), market protection,
and business continuity strategies to ensure product availability
and quality as demand increases in the market(s).This position is
part of the MEMP (Market Expansion, Market Protection) within
biotechnology R&D department and will be located in Sunnyvale,
CA, onsite. Our goal as a department, and as an overall
organization is to understand the needs of our customers and to
respond with accessible molecular diagnostic test systems as tools
to improve the health and integrity of all communities. Our
department is responsible for the active design of these systems
with guidance from our leadership and multidisciplinary (i.e.
interdepartmental) project core teams.In this role, you will have
the opportunity to:
- Lead, execute, and facilitate discussions regarding critical
NPD and post-launch studies. Examples of studies: Limit of
detection, Product Stability, Inclusivity/Exclusivity, FMECA,
Robustness/Reliability/DFM, Precision studies (repeatability and
reproducibility).
- Collaborate with interdisciplinary SMEs to develop novel
applications of our existing and future platforms and technology
while responding to changes in key markets and respond to updated
regulatory guidelines.
- Drive product development by communicating and providing
actionable data.
- Develop yourself into a multi-subject SME via coaching from
your team and the senior level Cepheid Scientific community.
- Work with a proven and talented team of scientists that are
dedicated to providing the best molecular diagnostic solutions to
the public.The essential requirements of the job include:
- PhD in a Biological Science field (e.g. Molecular Biology,
Biochemistry, Bioengineering, Chemistry, Biology or related field)
with 3+ years of industry related experience or academic equivalent
(e.g. MS with 6+ years of experience or BS with 8+ years of
experience).
- Experience working with microorganisms involved in infectious
diseases.
- Ability to balance multiple projects and priorities at the same
time with experience in interpreting and analyzing large scale
experimental data as well as results from clinical trials.
- Real time PCR or RT-PCR and product development experience with
experience in handling clinical specimens and being able to work in
a BSL-2 environment.
- Preparing and facilitating regulatory submissions to BSI, WHO,
and/or country specific regulatory agencies.It would be a plus if
you also possess previous experience in:
- Being a part of an NPD team that has successfully launched an
FDA cleared molecular diagnostic test.
- Being a part of a PLM team that has successfully submitted a
change notification for an FDA cleared molecular diagnostic
test.
- Knowledge of product development lifecycle process and design
control (Technical Feasibility and Design & Development phases,
phase gate exits). Experience implementing and following robust
design control processes for CE, US-IVD, and RoW tests.
- Experienced use in bioinformatic tools to assist in DOE, data
analysis, and clinical study design. Programs that we may use are:
Python, Minitab, JMP, MATLAB.Cepheid, a Danaher operating company,
offers a broad array of comprehensive, competitive benefit programs
that add value to our lives. Whether it's a health care program or
paid time off, our programs contribute to life beyond the job.
Check out our benefits at .The salary range for this role is
$144,000 to $190,000 USD annually. This is the range that we in
good faith believe is the range of possible compensation for this
role at the time of this posting. We may ultimately pay more or
less than the posted range. This range may be modified in the
future.This job is also eligible for bonus/incentive pay.We offer
comprehensive package of benefits including paid time off,
medical/dental/vision insurance and 401(k) to eligible
employees.Note: No amount of pay is considered to be wages or
compensation until such amount is earned, vested, and determinable.
The amount and availability of any bonus, commission, benefits, or
any other form of compensation and benefits that are allocable to a
particular employee remains in the Company's sole discretion unless
and until paid and may be modified at the Company's sole
discretion, consistent with the law.Given the essential job duties
of this position, the employee is required to be fully vaccinated
against COVID-19 (including applicable boosters) as a condition of
employment, subject to reasonable accommodation and applicable
law.Join our winning team today. Together, we'll accelerate the
real-life impact of tomorrow's science and technology. We partner
with customers across the globe to help them solve their most
complex challenges, architecting solutions that bring the power of
science to life.For more information, visit .Danaher Corporation
and all Danaher Companies are committed to equal opportunity
regardless of race, color, national origin, religion, sex, age,
marital status, disability, veteran status, sexual orientation,
gender identity, or other characteristics protected by law. We
value diversity and the existence of similarities and differences,
both visible and not, found in our workforce, workplace and
throughout the markets we serve.Our associates, customers and
shareholders contribute unique and different perspectives as a
result of these diverse attributes.The EEO posters are available
.We will ensure that individuals with disabilities are provided
reasonable accommodation to participate in the job application or
interview process, to perform crucial job functions, and to receive
other benefits and privileges of employment. Please contact us at
to request accommodation.
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Keywords: Futureshaper.com, Palo Alto , Staff Scientist, R&D MEMP, Other , Sunnyvale, California
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