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QC Project Manager- BLA Filing- Princeton NJ

General Description

The ideal candidate must have experience supporting regulatory submission readiness, with a strong focus on **tracking QC deliverables, testing schedules, and resource loading to ensure all activities align with the Client’s July 2026 BLA filing commitment** .

This role is responsible for establishing QC programs and ensuring GMP-compliant testing and release of materials, intermediates, and finished products under FDA, EU, and international regulations. The candidate will lead laboratory investigations (OOS, OOT, OOE), support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.

Essential Functions

+ Utilize project management tools to **track QC testing deliverables** , ensuring execution aligns with the July 2026 BLA submission timeline. Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.

+ Support preparation and review of **technical reports and QC documentation required for the BLA** , ensuring timely completion and regulatory accuracy.

+ Create, maintain, and monitor **QC testing trackers** , documenting tests, timelines, assigned analysts, sample workflows, and status updates.

+ Facilitate and maintain a **resource loading tracker** , aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.

+ Author technical documents including SOPs, test methods, method validation protocols/reports, and material specifications.

+ Lead investigations for **OOS, OOT, OOE** results, ensuring thorough root-cause analysis and compliant documentation.

+ Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.

+ Lead the establishment and maintenance of a **stability program** , ensuring data availability for regulatory filing.

+ Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.

+ Perform additional duties as required to support QC, compliance, and BLA submission needs.

Core Competencies, Knowledge & Skill Requirements

+ Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, or related scientific discipline.

+ **7–12 years of experience in an FDA-regulated pharmaceutical or biotechnology environment** , with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).

+ Proficiency with analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.

+ Strong working knowledge of **USP/EP** , **cGMP** , **EU GMP** , and analytical compliance requirements.

+ Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.

+ Proven experience tracking testing deliverables, coordinating QC schedules, and supporting regulatory timelines.

+ Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.

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.