Bioanalytical QC Supervisor

Kelly Services • Princeton, NJ • 11h ago

Job Title: QC Chemistry Supervisor- Contract to Hire- Princeton NJ

The QC Chemistry Supervisor will lead all Quality Control Chemistry laboratory operations to support GMP manufacturing, testing, and release of raw materials, intermediates, and finished products in compliance with FDA, EU, and international regulatory standards.

Key Responsibilities:

Lead and manage the setup and operationalization of a new QC Chemistry laboratory. Conduct or supervise bench-level testing as needed.

Oversee daily QC Chemistry lab operations, ensuring timely and accurate testing for in-process materials, drug substance (DS), drug product (DP), and stability samples. Maintain compliance with FDA, EU and cGMP requirements.

Oversee the development and implementation of SOPs, test methods, specifications, and related documentation.

Lead and manage investigations related to OOS results, deviations, laboratory errors, and instrument malfunctions; implement effective CAPAs.

Manage and coordinate method transfers and method validation/verification activities, including strategy development and protocol/report approvals.

Required Qualifications:

Bachelor's or advanced degree in Chemistry, Biochemistry, Pharmaceutical

Minimum 5-7 years of relevant industry experience in a cGMP-regulated pharmaceutical or biotechnology environment.

At least 2 years of leadership or supervisory experience in a QC laboratory setting.

Strong working knowledge of analytical techniques including HPLC, UHPLC, size exclusion chromatography, capillary electrophoresis, cIEF, peptide and oligo mapping, etc. Familiarity with USP, EP, and ICH guidelines.

Experience with analytical method validation, method transfers, and instrument qualification (IQ/OQ/PQ). Proficiency with laboratory documentation systems and software (e.g., LIMS, Empower, chromatography data systems).

In-depth understanding of cGMP/GLP principles and regulatory expectations

High attention to detail with a commitment to data integrity and quality.

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.

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