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Johnson & Johnson Innovative Medicine · 5 hours ago

QC Bioassay Specialist

Wilson, NC

Full-time

Onsite

Senior Level

6+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to building a world where complex diseases are managed effectively. They are seeking an experienced Bioassay Specialist to join their Quality Control team, responsible for developing and validating bioassay methods in a GMP-regulated environment.

Pharmaceuticals

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

Qualification

ADCCCDCELISAGMP complianceMethod validationRegulatory complianceCommunication skillsProblem-solving skillsCollaborationDetail-orientedOrganizational skills

Required

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