Janssen Supply Group, LLC, a member of Johnson & Johnson's
Family of Companies, is recruiting for a Senior Stability Laboratory Supervisor
to be located in Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson,
what matters most is helping people live full and healthy lives. We focus on
treating, curing and preventing some of the most devastating and complex
diseases of our time. And we pursue the most promising science, wherever it
might be found.
Janssen Supply Group, LLC is a global organization responsible for
producing and supplying medicines to markets around the world. With
quality as its primary focus, this group collaborates with Research &
Development and Commercial partners to deliver life-changing solutions for
patients in need.
Janssen Pharmaceuticals, Inc. provides medicines for an array of
health concerns in several therapeutic areas, including Cardiovascular,
Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We
collaborate with the world for the health of everyone in it.
Senior Stability Laboratory Supervisor will:
- Supervise a team of laboratory analysts that perform stability
testing of pharmaceutical drug products.
- Interact with internal and external global customers to resolve
issues and provide stability expertise.
- Perform and/or manage the completion of laboratory investigations
including the authorization of reanalysis plans and approval of invalid events.
- Coordinate and perform all aspects of routine stability testing. This includes scheduling test assignments and
making decisions on data acceptability through data trending and review.
- Make personnel decisions related to laboratory staffing.
- Author, review and/or approve laboratory-controlled documents,
e.g., laboratory SOPs, change controls, work instructions, technical
justifications, specifications, and methods.
- Ensure personnel are trained and develop direct reports so that
they can conduct and author investigations.
- Ensure laboratory housekeeping is maintained, that the appropriate
laboratory supplies and reference standards are available, and verify that instrument
calibration is performed.
- Provide technical guidance to laboratory staff, leading or
assisting with troubleshooting analytical issues, and identify/communicate any
potential issues/product trends to manager.
- Perform method transfers when required.
- Ensure and enforce laboratory adherence to cGMPs, ICH, Janssen
global and local procedures, laboratory environmental, health, and safety
procedures, DEA requirements for
controlled substances, and the Credo.
- A minimum of Bachelor of Science (or equivalent degree) in
Chemistry, Engineering, or a related scientific discipline is required.
- A minimum of 6 years of experience in an analytical laboratory
(R&D, QC, or Stability) is required.
- Significant knowledge of analytical chemistry and cGMPs to
troubleshoot and resolve technical laboratory or analytical-related issues is
- Demonstrated proficiency in the use and/or qualification of analytical
instrumentation (one or more of the following: UPLC, HPLC, GC,
Dissolution/Release, Rate, UV, and Spectroscopy) is required.
- A basic understanding of statistical principles used to evaluate test
results is required.
- Prior supervisory experience is preferred.
- Experience with laboratory IT systems, e.g., Empower, LIMS, and
TrackWise (event management/CAPA system), is preferred.
- This position will be located in Titusville, NJ, and this
individual must have flexibility to travel to Raritan, NJ on occasion,
depending on business needs.
United States-New Jersey-TitusvilleOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function