QC Bioassay Specialist

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 Med Tech, 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.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Wilson, North Carolina, United States of America

Job Description:

Job Description

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.

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We are seeking an experienced Bioassay Specialist with strong expertise in cell-based and ligand-binding assays
, specifically Antibody-Dependent Cellular Cytotoxicity (ADCC),
Complement-Dependent Cytotoxicity (CDC), and Enzyme-Linked Immunosorbent Assay (ELISA), to join our Quality Control (QC) team at a newly established large molecule manufacturing site in Wilson, NC. As one of the first fifteen employees in the QC department, you will play a critical role in building laboratory capabilities, authoring procedures, and transferring complex bioassay methods in a GMP-regulated environment.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

Key Responsibilities

• Establish QC Bioassay Capabilities: Support the build-out of QC laboratory infrastructure and workflows for potency and immunoassays.
• Method Transfer & Validation: Lead comparative testing and transfer of ADCC, CDC, and ELISA methods for biologics, ensuring compliance with global regulatory standards (FDA, EMA, ICH).
• Procedure Development: Author, review, and approve SOPs, work instructions, and technical documentation for bioassay testing.
• Technical Expertise: Serve as the subject matter expert for bioassay techniques; train and mentor incoming QC personnel on assay execution and data integrity principles.
• Cross-Functional Collaboration: Partner with MSAT, QA, and Operations to ensure seamless method implementation and resolve technical challenges during scale-up and commercialization.
• Compliance & Quality: Maintain adherence to GMP, compendial requirements, and site-specific quality standards. Support regulatory inspections and contribute to observation responses.
• Continuous Improvement: Identify and implement process improvements to enhance efficiency and robustness of bioassay testing.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Immunology, or related field; advanced degree preferred.
• Minimum 6 years of experience in QC or analytical development within biologics or pharmaceutical manufacturing.
• Strong expertise in ADCC, CDC, and ELISA assays, with proven experience in method validation, transfer, and regulatory compliance in a GMP environment.
• Knowledge of compendial standards and global regulatory guidelines.
• Excellent communication skills and ability to thrive in a dynamic, start-up environment.

Key Competencies

• Entrepren…