The Cardiovascular &
Specialty Solutions (CSS) Group, part of the Medical Devices sector within
Johnson & Johnson, is recruiting for a Senior Scientist aligned
to Advanced Sterilization Products (ASP), located in Irvine, CA.
The CSS Group consists of six diverse
businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense
Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a
diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention,
Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and
Non-Surgical Aesthetics, and Reprocessing.
Advanced Sterilization Products (ASP), a Johnson & Johnson company,
truly makes a difference by Protecting Lives against Infection®. ASP
has been innovating since 1987 to help healthcare facilities protect patients
with best-in-class infection prevention solutions. Learn more about Advanced
Sterilization Products at www.aspjj.com/us
The Senior Scientist will report directly to
the Laboratory Supervisor or Laboratory Manager and will perform complex
testing in compliance with laboratory test methods and procedures to support
the manufacturing and timely delivery of product to customers, and stability
studies (75 to 100%).
- The Senior
Scientist will receive general instructions about required tasks and
- Work will be
well defined and will be reviewed for accuracy upon completion.
- The Senior
Scientist is expected to apply standard practices and techniques in
specific situations and to recognize discrepancies in results and follow
operations through a series of detailed steps and processes.
the Senior Scientist has accountability and ownership to maintain
laboratory instruments in their qualified state as well as troubleshoot
instrumentation in the event of instrument issues.
- Operating in
accordance with current GMPs. This includes the ability to understand and
apply SOPs and use GMPs for documenting, testing and maintaining accurate
increasingly complex testing to support stability
- Supporting product
development, validation and test method transfer activities
and investigation of non-conforming laboratory test results as well
as the communication of stability and quality issues to the next level of
initial and final review of data generated by peers and contract
daily calibrations and routine maintenance of laboratory instrumentation
and equipment according to current SOPs.
- Assisting in
various other duties which contribute to the organization and function of
for ensuring personal and company compliance with all Federal, State,
local and company regulations, policies and procedures for Health, Safety
and Environmental compliance.
for ensuring that laboratory personnel follow all company guidelines
related to Health, Safety and Environmental practices and that all
resources needed to do so are available.
for investigations regarding product or lab OOS/OOT
stability data from internal and external manufacturers
other related duties as assigned by management.
The Senior Scientist should be able to serve
as an expert in technical areas (minimally15-25%).
Major responsibilities will include:Qualifications
Bachelor of Science Degree is required in chemistry (preferred),
biochemistry or related science. A Master of Science degree or PhD is
- One of the following
combinations of minimum experience and education is required: Greater
than 5 years’ experience with Bachelor of Science Degree performing
progressively advanced duties at the Scientist 2 Level or equivalent
is required; or, Greater than 3 years’ experience with Master of Science
Degree performing progressively advanced duties at the Scientist 2 Level
or equivalent is required; or, 0-2 years’ experience with a PhD is
- HPLC, GC, UV-Vis,
Densitometer, FTIR is desired.
- Knowledge of
LIMS is preferred
- Proficiency with MS Office Suite
with method development, review & validation is preferred.
- Ability to
work independently to perform testing with limited supervision is
interpersonal, organizational and communication skills are required.
- Must be able
to interact well with peers and colleagues.
candidates are preferred.
- Good working
knowledge of quality compliance is heavily preferred.
- Must be able to lift 20 lbs, must be able to
walk, stand or sit to perform job tasks.
Work may be repetitive in nature.
- Vision abilities required by this job include close vision.
position is located in Irvine, CA and may require limited travel.
Ethicon Inc. (6045)Job Function
Quality AssuranceRequisition ID
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