QC Separations Specialist

Johnson & Johnson Innovative Medicine • Wilson, NC

14d

About The Position

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/innovative-medicine We are seeking an experienced Separations Specialist with expertise in High-Performance Liquid Chromatography (HPLC) 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 foundational role in building laboratory capabilities, authoring procedures, and transferring analytical 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 Chemistry, Biochemistry, or related field; advanced degree preferred.
• Minimum 6 years of experience in QC or analytical development within biologics or pharmaceutical manufacturing.
• Strong expertise in HPLC and related separations techniques.
• 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 Capabilities: Support the build-out of QC laboratory infrastructure and workflows for separations testing.
• Method Transfer & Validation: Lead comparative testing and transfer of HPLC-based 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 separations testing.
• Technical Expertise: Serve as the subject matter expert for chromatographic techniques; train and mentor incoming QC personnel.
• Cross-Functional Collaboration: Partner with MSAT, QA, and Operations to ensure seamless method implementation and resolve technical challenges.
• Compliance & Quality: Maintain adherence to GMP, compendial requirements (USP, EP, JP), 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 separations testing.

What This Job Offers

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