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Job Title: Analyst, QC Biochemistry- Princeton NJ

**Department:** Quality Control; **Reports to:** QC Manager

General Summary:

The QC Biochemistry Analyst is responsible for performing laboratory activities to support the GMP-compliant testing, release, and stability of biologic products, including monoclonal antibodies. This role ensures testing is conducted in alignment with FDA, EU, and international regulatory standards, as well as internal quality systems and procedures.

Technical Skills and Knowledge:

+ Hands-on experience with analytical techniques such as:

+ Quantitative PCR (qPCR) for residual DNA

+ Host Cell Protein (HCP) ELISA

+ Residual Protein A ELISA

+ Binding Activity ELISA

+ Capillary Electrophoresis (CE)

+ Capillary Isoelectric Focusing (cIEF)

+ Strong understanding of cGMP, FDA, EU GMP, and USP/EP regulatory requirements.

+ Familiarity with equipment and instrument validation processes.

Key Responsibilities:

+ Perform QC Biochemistry testing on drug substance (DS), drug product (DP), and stability samples to support lot release and manufacturing timelines.

+ Maintain accurate and timely documentation of test results in accordance with cGMP and GDP guidelines.

+ Conduct and support investigations related to OOS (Out of Specification), OOT (Out of Trend), deviations, and invalid assays.

+ Implement effective corrective and preventive actions (CAPAs) based on root cause analysis.

+ Participate in internal and external GMP audits and inspections as required.

+ Support method transfers and validation activities, including protocol generation, execution, and reporting.

+ Act as a subject matter expert (SME) in one or more core biochemical assay areas.

Required Qualifications:

+ Bachelor’s degree (or higher) in Biochemistry, Chemistry, Biotechnology, or a related scientific discipline.

+ Minimum 2 years of experience in a QC or analytical laboratory environment within the biotech or pharmaceutical industry under FDA regulations.

+ 5+ years of relevant experience accepted in lieu of higher education.

Core Competencies:

+ Exceptional attention to detail and commitment to data integrity.

+ Team-oriented with leadership capabilities and a proactive, hands-on approach.

+ Flexible and adaptable to changing priorities or responsibilities.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.