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

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

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

• Experience working in Biosafety Level (BSL 2, BSL2+) lab 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 document observations during laboratory testing

• Requires up to 5% of domestic travel

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills: