Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control - Clinical Release & Stability (CRS) in Malvern, PA!
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The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 - 20 other Analysts within a functional Clinical Release and Stability (CRS) Laboratory and report to a QC CRS Supervisor.
Key Responsibilities:
- Conduct analytical biological testing of clinical and commercial drug product/drug substance samples
- Perform peer reviews and approvals of laboratory data
- Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data
- Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management
- Perform Instrument Calibration and/or Preventative Maintenance
- Update CRS-owned documents using the Document Management System (DMS)
- Order/receive supplies and lead inventory
- Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities
- Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight
- Act as a peer subject matter authority in assessing talent by participating in panel interviews for job
- Complete invalid assay and general laboratory investigation records
- Complete corrective and preventative actions (CAPA) as assigned
- Assist in the execution of internal audits
Qualifications
Education:
- Minimum of a Bachelor's or equivalent degree in Biology, Biochemistry, Microbiology, Chemistry or related field is required
Experience and Skills:
Required:
- Minimum two (2) years of relevant work experience
- Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry
- Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
- Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories such as qPCR, cell culture, Flow Cytometry, and/or ELISA
- Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols
- Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)
Preferred:
- CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience
- Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
- Ability to complete equipment and software qualification protocols
- Experience developing and setting long-term objectives
- Experience working in Biosafety Level lab (BSL 2, BSL2+) or aseptic facility
- Experience, training, or certification in Lean, Six Sigma, or Process Excellence tools & methodologies
- Knowledge of EU/FDA guidance
Other:
- Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice outside of Monday-Friday 8:00AM to 4:30PM.
- Requires the physical ability to lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting, and ability to perform visual inspections of materials (color, appearance, particles, etc.) and to detail observations during laboratory testing
- Requires up to 5% of domestic travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.