Associate Scientist, Bacterial Vaccine GCLP Specialist

Job description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Associate Scientist, located in Raritan, 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 Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.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.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The candidate will be part of an established team working to evaluate clinical trial samples for immunological responses to vaccination by internal vaccine candidates. As a GCLP documentalist, the candidate will support laboratory instrument qualification and change control, qualifying Excel tools, filing change control documentation, writing qualification reports, writing SOPs, supporting SOP development, maintaining laboratory inventory records (including chemical inventories, MSDS files and waste disposal) and working with archiving personnel. Responsibilities include:
· Understanding and applying Janssen QA systems and requirements to maintain GCLP-compliant processes within a Clinical Assays Laboratory environment, coordinating efforts with Janssen QA personnel
· Instrument and procedural validations in support of GCLP activities
· Provide guidance and assist in preparations for internal, external and regulatory audits and will draft associated audit and CAPA responses and reports
· Perform in vitro assays in support of ongoing clinical trials under Good Clinical Laboratory Practice (GCLP) conditions
· Maintain laboratory records according to GCLP requirements

Desired profile

Qualifications :

·  Bachelors in a life science with at least 3 years experience in a working environment under GMP, GCP, GLP or GCLP principles is required
·  Experience with internal and external audits, including interactions with governmental regulatory agencies is required
·  A minimum of two years of laboratory experience is required
·  Experience working with Biosafety Level (BSL) II bacterial pathogens is preferred
·  Familiarity with ELISA procedures and analysis, basic microbiology, aseptic technique, and general safe laboratory practices is preferred
·  Familiarity with the LIMS LabWare program is preferred
·  Experience working in a GCP laboratory, with detailed understanding of GCLP or GLP is required
·  Familiarity with laboratory processes and experience working with tissue culture cells and bacterial cultures, and other microbiological and molecular biology techniques is preferred
·  Proficient in Microsoft Word, PowerPoint, and Excel is required