R&D, Senior Staff Scientist, Consumable Assay Technology
Company: Disability Solutions
Location: Carlsbad
Posted on: November 1, 2024
Job Description:
Roche fosters diversity, equity and inclusion, representing the
communities we serve. When dealing with healthcare on a global
scale, diversity is an essential ingredient to success. We believe
that inclusion is key to understanding people's varied healthcare
needs. Together, we embrace individuality and share a passion for
exceptional care. Join Roche, where every voice matters.The
PositionWe advance science so that we all have more time with the
people we love.GenMark, a member of the Roche Group, is dedicated
to providing world-class solutions for multiplex testing, with
enhanced features that contribute to Roche's commitment to helping
diagnose infectious diseases and reduce antibiotic resistance. As
the world's #1 provider of companion diagnostics, the Roche Group
offers an unrivaled experience in developing and commercializing
predictive tests that enable personalized treatment strategies for
patients. As a member of our R&D team, the Senior Staff
Scientist will define and execute multiple product improvements to
meet customer needs, address internal needs such as manufacturing
process improvements, and other product lifecycle scientific needs
and may help develop next generation products. In addition, the
Senior Staff Scientist will partner and lead closely with internal
scientists, engineers and external partners to develop protocols
for microfluidic consumable and assay development; will work
cross-functionally to drive product, process, and tool improvements
to ensure fact-based scientific, engineering, and analytical best
practices and principles are utilized.
- You will maintain and advance the broad knowledge of
principles, best practices and literature in molecular biology,
assay integration, protein / enzyme analytical sciences and
bioengineering / consumables functionality.
- You will manage, evaluate and approve complex design changes
across multiple disciplines to ensure customer and internal
requirements are met
- You will create partnerships with RA/QA to ensure compliance to
applicable legal and regulatory standards and build collaborative
partnerships with local GenMark staff and with global teams at
Roche
- You will design, conduct and direct complex experiments and
characterization studies for assay conditions and material
variables, with consideration for critical to quality
attributes
- You will design multifactorial experiments on and off cartridge
and consumables to troubleshoot and resolve failure modes
- You will conceptualize and develop analytical methodologies to
aid product characterization and process development, for critical
parameter management
- You will optimize existing or develop new molecular diagnostics
assays.
- You will lead Engineering Change Orders, such as BOM, SPECs,
Manufacturing work instructions; you will be responsible for data
processing, graphing, design of experiments (DOE), and statistical
analysis (ANOVA)Who You Are:(Required)
- You have a Ph.D degree in the Life Sciences, Physical Sciences,
BioEngineering (or related discipline) with 10+ years of
professional product development experience after Ph.D/Post Doc; or
a Masters in the Life Sciences, Physical Sciences, Bioengineer (or
related discipline) with 16+yrs of professional experience after
graduation; or a BS in the Life Sciences, Physical Sciences,
BioEngineering (or related discipline) with 18+ years of
professional product development experience after graduation
- You have successfully developed 5+ multiple, highly complex
products and led complex projects leading to
commercialization.
- You have a significant (6-15) publication, patent and product
portfolio.
- You have demonstrated experience in IVD/FDA regulated, clinical
diagnostics, reagent or consumable, molecular biology tools product
development with a track record of successful product launches with
a proven track record of multiple product optimization through
design of experiments (DOE); you have demonstrated knowledge of
sample prep and amplification methods; experience with assay
integration or assay automation and software analysis; experience
partnering with operations transfer / process development
teams.
- You have demonstrated experience in test protocol development,
execution and reporting including developing accelerated and real
time stability protocols.
- You have a demonstrated level of expertise in: IVD/Diagnostics;
Design Control; QMS; Molecular Biology expertise for RNA and DNA
assays; BSL II experience, infectious disease testing
- You have leadership experience in a matrixed environment;
demonstrated ability to coach and influence others; you have
effective analytical problem solving, judgment and decision making
skills; you have the ability to read, write and analyze complex
documentsPreferred:
- PhD in the Life Sciences, Physical Sciences, BioEngineering (or
related discipline) is preferred.
- You have experience with various DOE tools (JMP or R
preferred)
- You have experience with electrowetting movements and/or
microfluidics
- You have the ability to respond effectively to sensitive
inquiries, customer inquiries or complaints as well as communicate
effectively both orally and in writing with management, peers and
individuals
- You have the ability to complete work in a timely, accurate and
thorough manner; you are able to think and work both tactically and
strategically; you are hands-on, self-directed, and organized
- You have demonstrated communication skills including the
ability to communicate with multiple levels within the
organization; you have strong presentation and influence skillsWORK
ENVIRONMENTThe essential functions of the job are usually performed
in an environmentally controlled facility where the noise level in
the work environment is usually moderate. This position may involve
a combination of office and biotechnology laboratory environments.
The employee may be exposed to hazardous chemicals, blood borne
pathogens and automated equipment. While performing the job duties,
the employee is regularly required to sit; reach with hands and
arms and talk or hear. The employee is frequently required to stand
and walk. The employee may sometimes be required to lift and/or
move up to 35 pounds. Specific vision abilities required by this
job include close vision, distance vision, color vision and ability
to adjust focus.This position is based in Carlsbad, CA.Relocation
benefits are not available for this position. The expected salary
range for this position based on the primary location of Carlsbad,
CA is $121,800 - $226,500. Actual pay will be determined based on
experience, qualifications, geographic location, and other
job-related factors permitted by law. A discretionary annual bonus
may be available based on individual and Company performance.This
position also qualifies for the benefits detailed at the link
provided below.Who we areGenMark is now a proud member of the Roche
Group, more than 100,000 people across 100 countries are pushing
back the frontiers of healthcare. As a global leader in healthcare,
Roche Diagnostics offers a broad portfolio of products, tools and
services that help in the prevention, diagnosis and management of
diseases like HPV, HIV, hepatitis and diabetes as well as other
medical conditions, such as fertility and blood coagulation. With
the addition of GenMark to the Roche Group, syndromic infectious
disease diagnostics is now added to the long list of disease states
and conditions that the Roche Group addresses. GenMark's ePlex true
sample-to-answer system offers unique solutions to address the most
significant challenges facing clinical laboratories, while
supporting hospital systems to deliver patient-centered,
value-based care. ePlex streamlines the diagnostic workflow from
physician order entry to the final test report and is the true
sample-to-answer solution designed to improve patient care, reduce
costs, and increase lab efficiency. GenMark is headquartered in
Carlsbad, California.GenMark is an equal opportunity employer and
strictly prohibits unlawful discrimination based upon an
individual's race, color, religion, gender, sexual orientation,
gender identity/expression, national origin/ancestry, age,
mental/physical disability, medical condition, marital status,
veteran status, or any other characteristic protected by law.
Keywords: Disability Solutions, Moreno Valley , R&D, Senior Staff Scientist, Consumable Assay Technology, IT / Software / Systems , Carlsbad, California
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