Technical Leader - Assay Development
Company: Disability Solutions
Location: Carlsbad
Posted on: October 3, 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.Roche is the world's #1 provider of companion
diagnostics, offering unrivaled experience in developing and
commercializing predictive tests that enable personalized treatment
strategies for patients.The Technical Leader, Assay Development
(Technical Leader) will have expertise in consumable metrology,
reagent analytical chemistry, system integration, genomics,
sequencing, infectious disease, biochemistry assays, development of
ambient stable formulations including lyophilization, and molecular
biology, including principles of nucleic acid hybridization, probe
and primer design, nucleic acid extraction, laboratory automation,
as well as a background in the integration of molecular biology
methods with complex consumable devices for in vitro diagnostics.
In addition, the Technical Leader will have a demonstrated
understanding of the Diagnostic Design Control Process with prior
experience designing and developing nucleic acid-based "sample to
answer" molecular diagnostic products within a regulated
environment.The Technical Leader will lead a team of scientists,
engineers and research associates in research and development
activities. This person will provide cross-functional team
leadership to ensure achievement of project milestones according to
timeline, budget and specifications. The Technical Leader will
build and provide leadership for an effective team in a high growth
environment including hiring, on-boarding, developing, goal
setting, performance improvement and disciplinary actions; creating
a positive environment and instilling a sense of urgency and strong
can-do attitude in the team.
- You will direct and manage multiple ePlex product and process
characterization initiatives; you will provide cross-functional
team leadership to ensure achievement of project milestones
according to timeline, budget and specifications.
- You will work closely with manufacturing to complete key
product and process characterization activities to ensure a robust
production process that meets performance expectations.
- You have experience in the development of stability protocols,
QC protocols, design for manufacturability, use of DOE, critical
parameter management, and optimization of critical to quality
attributes
- You will cooperate with Regulatory and Quality departments for
successful compliance with regulatory guidelines and design control
processes.
- You will partner with finance, marketing, IP, legal and product
care leadership functions to ensure all stakeholder inputs are
considered; providing clear communication in tradeoff decisions
between cross functional stakeholders; you will provide regular
updates to executive leaders
- You will manage staff; provide staff with coaching, training
and opportunities to develop skills, and give ongoing, constructive
and timely feedback on performance and progress toward goals and
expectations
- You will set challenging team goals and ensure scientific and
statistical best practices are used to attain these goals.
- You will drive team debate/discussions around key issues that
determine product quality, functionality or schedule; you will lead
development of scenarios and alternatives that can guide strategic
decision making.
- You will decide on project execution priorities and technical
approach in accordance with cross-functional evaluation and risk
assessment; you will develop project plans and direct execution in
line with approved budgets, timelines, risk mitigation plans, and
resources.This role is on-site in Carlsbad, CA.There are no
relocation benefits for this role.Who You Are:(Required)
- You have a Ph.D. degree in Biochemistry, Chemistry,
Microbiology, Molecular Biology, Biomedical Engineering, or related
field with 15+ years of experience in medical diagnostic product
development
- You have 10+ years of leadership experience managing large
scientific teams within the diagnostics/assay development
space.
- You have a proven track record of numerous successful product
launches.
- You have demonstrated knowledge in late-stage development and
product transfer activities for IVDs, preferably for unit-use or
point-of-care consumable devices
- You have demonstrated experience working with various health
authorities, including the FDA; have made significant contributions
to the successful clearance of an FDA regulated medical
device.Preferred:
- You have demonstrated ability to understand complex scientific,
engineering and business concepts
- You have demonstrated experience collaborating with
cross-functional teams; creating and maintaining project plans,
budgets and schedules
- You have excellent organizational skills, including the ability
to efficiently evaluate, prioritize and handle multiple changing
projects and priorities
- You have strong written and verbal communication skills;
including the ability to communicate with all levels within the
organization.
- You have experience working collaboratively, fostering
professional and constructive relationships as part of a team;
while also working independently to produce data and meet
challenging timelines and goalsWORK 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
$196,200 - $364,400. 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, Encinitas , Technical Leader - Assay Development, Accounting, Auditing , Carlsbad, California
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