Quality Control- Clinical Release & Stability (CRS) Analyst

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Quality Control- Clinical Release & Stability (CRS) Analyst to be in Malvern, PA,

Purpose: The QC CRS Analyst is responsible for conducting biochemical and testing of drug substance, final product release and characterization samples, and critical reagent qualifications of cell and gene therapy products, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. This available position will primarily focus on work supporting qPCR. 

You will be responsible for:

• Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical drug substance, drug product, characterization, and/or critical reagent samples 

• Perform peer reviews and approvals of laboratory data 

• Use electronic systems (eLIMS, MES, Empower, etc.) for execution and documentation of laboratory data 

• Support of New Product Introductions (NPI) in groups of 3-6 analysts 

• Support analytical method qualification, validation, and transfer into the CRS lab, owning change control actions, generation of new documentation, and completing testing activities with mentorship from Sr. Analysts on transfer activities 

• Perform Instrument Calibration and/or Preventative Maintenance, as needed 

• Order/receive supplies and manage inventory 

• Update CRS-owned documents using the Electronic Document Management System (EDMS)  

• Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight 

• Complete invalid assay and support laboratory investigation records 

• Complete corrective and preventative actions (ACTs), as assigned 

• Assist in the execution of internal audits or inspections 

Qualifications / Requirements:

• Minimum of a Bachelor’s or equivalent degree in Biology, Biochemistry, Microbiology, Chemistry or related field is 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 the analytical technology of qPCR 

• 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 

• Experience with analytical technologies used in the CRS Laboratory such as qPCR, cell culture, Flow cytometry, and/or ELISA 

• 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  <