Senior Scientist
Location:
Irvine , California
Posted:
April 02, 2017
Reference:
2694170217-en-us

 

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 results expected.
  • 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.
  • Additionally, 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 laboratory records.
  • Performing increasingly complex testing to support stability
  • Supporting product development, validation and test method transfer activities
  • Initiation and investigation of non-conforming laboratory test results as well as the communication of stability and quality issues to the next level of management
  • Providing initial and final review of data generated by peers and contract laboratories
  • Performing 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 the laboratory.
  • Responsibility for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
  • Responsibility 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.
  • Responsible for investigations regarding product or lab OOS/OOT
  • Review stability data from internal and external manufacturers
  • Performing 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

Qualifications

 

  • A Bachelor of Science Degree is required in chemistry (preferred), biochemistry or related science. A Master of Science degree or PhD is preferred.
  • 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 required.
  • HPLC, GC, UV-Vis, Densitometer, FTIR is desired.
  • Knowledge of LIMS is preferred
  • Proficiency with MS Office Suite
  • Experience with method development, review & validation is preferred.
  • Ability to work independently to perform testing with limited supervision is required.
  • Excellent interpersonal, organizational and communication skills are required.
  • Must be able to interact well with peers and colleagues.
  • Self-motivated 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.
  • This position is located in Irvine, CA and may require limited travel.


Primary Location
United States-California-Irvine
Organization
Ethicon Inc. (6045)
Job Function
Quality Assurance
Requisition ID
2694170217

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