QC Bioassay Specialist

Johnson & Johnson • Wilson, NC

3d • Onsite

About The Position

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 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.

Requirements

• 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.

Nice To Haves

• Entrepreneurial mindset with a passion for building new capabilities.
• Detail-oriented and highly organized, with strong problem-solving skills.
• Ability to work independently and collaboratively across functions.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees