Jobs for People with MS: National MS Society

Job Title: Senior QC Biochemistry Scientist

Job Description:

Are you passionate about ensuring the quality and safety of pharmaceutical products? We are seeking a Senior QC Biochemistry Scientist to join our team and play a pivotal role in supporting GMP manufacturing, testing, and release activities. As a key member of our Quality Control team, you will lead and execute biochemistry assay validation and transfer activities, ensuring compliance with FDA/EU regulations and international standards.

Essential Functions:

• Lead and execute QC biochemistry assay validation and transfer activities, including testing for Drug Substance, Drug Product release, and stability testing, ensuring timely generation and reporting of test results to support manufacturing operations.

• Support routine operations, including instrument qualification and maintenance, SOP generation and revision, testing record keeping, and more.

• Manage inventory of reagents and supplies for the laboratory, ensuring uninterrupted workflow.

• Lead investigations of OOS, discrepancies, errors, and failures, implementing necessary corrective actions.

• Participate in internal and external GMP audits to uphold quality standards.

• Lead method transfer and method validation activities, preparing protocols and reports.

• Train junior-level analysts and new hires, fostering a culture of continuous learning and development.

• Serve as a subject matter expert in various areas of required testing, providing guidance and expertise to the team.

Core Competencies, Knowledge, and Skills:

• Working knowledge and experience in an FDA-regulated biotechnology or pharmaceutical company.

• Expertise in residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis (cIEF), including qualification, assay validation, and transfer activities.

• Familiarity with USP/EP and cGMP/EU GMP and ICH guidelines.

• Strong leadership and team management skills, with the ability to inspire and motivate others.

• Excellent communication skills, both written and verbal, with the ability to convey complex information effectively.

• Strong analytical and problem-solving abilities, with a hands-on approach and a 'can do' attitude.

• Exceptional attention to detail, with the ability to prioritize tasks and manage time effectively in a fast-paced environment.

If you are looking for an opportunity to make a meaningful impact in a dynamic and collaborative environment, we invite you to apply for this exciting position. Join us in our mission to deliver high-quality pharmaceutical products that improve the lives of patients worldwide.

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 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.

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.