Job Title: Senior QC Biochemistry Scientist
: 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 ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
