Analytical Science & QC Specialist

OBJECTIVES: Join our mission to advance biologics and vaccine development! As an Analytical Science & QC Specialist with a focus on Cell Biology and/or In-Process Control (IPC), you'll play a critical role in ensuring product quality, compliance, and innovation during Drug Substance (DS) and Drug Product (DP) manufacturing. This position supports day-to-day laboratory operations, analytical method transfers, data trending, and quality investigations in a dynamic, collaborative environment aligned with GMP standards and Hilleman-laboratories Quality Policies. Support biologics and vaccine development through analytical science and quality control. Ensure product quality and compliance in a dynamic, collaborative environment. Focus on generating critical data and advancing vaccine development. RESPONSIBILITIES: General Maintain high standards of lab operations including housekeeping, equipment maintenance, inventory management, and autoclaving to ensure smooth workflows. Develop, review, and update QC and Analytical Sciences (IPC) SOPs for both GMP and non-GMP testing environments. Perform accurate testing, documentation, and timely reporting in compliance with cGMP and non-GMP standards to support manufacturing and product release. Train and mentor analysts on testing methods and SOPs; lead projects such as equipment qualification, method validation, and process improvements. Troubleshoot and resolve analytical equipment and testing issues promptly to maintain operational efficiency. Investigate quality incidents and lab deviations, lead Root Cause Analysis (RCA), and implement corrective and preventive actions (CAPA). Collaborate with cross-functional teams and act as a liaison for tech transfer and external partners, ensuring alignment with Master Plans and timelines. Drive process improvement initiatives to enhance efficiency and product quality. Manage sample logistics and coordinate raw material testing, quality inspections, and ERP documentation. Conduct advanced laboratory testing for vaccine development, including virus titration, HPLC, and biochemical methods. Serve as Subject Matter Expert (SME) for IPC topics, providing technical solutions and supporting cross-functional alignment. Lead environmental monitoring and microbiological testing to uphold safety and regulatory compliance. Ensure data integrity, participate in audits, and support Quality Management System (QMS) activities including document control and change management. Coordinate with vendors and suppliers for quality compliance of reagents, standards, and services. Oversee equipment lifecycle management including calibration, preventive maintenance, and validation documentation. Support method development teams with practical QC insights. Promote laboratory safety and environmental compliance. Prepare reports and KPIs to inform management and stakeholders on lab performance and quality metrics. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Basic Qualifications: Bachelor’s degree, diploma, or equivalent in science, engineering, or related technical field. 3-7 years’ experience in Quality Control, Analytical Science & Technology, or pharmaceutical manufacturing (preferably vaccines or biologics). Strong knowledge of QC lab operations, analytical testing, troubleshooting, and biologics manufacturing, including aseptic techniques and cleanroom practices. Familiarity with regulatory guidelines (FDA, EMEA, ICH Q7) relevant to vaccines and biologics. Preferred Key Skills, Abilities, and Competencies: Deep understanding of regulatory environments, GMP, microbiology, contamination control, and QC systems. Experience with LIMS, electronic lab notebooks, and QC analytical equipment. Proficiency in advanced analytical techniques such as virus titration, HPLC, biochemistry, and physical chemistry methods. Excellent communication skills with the ability to engage stakeholders at all levels. Proven ability to coordinate cross-functional teams and drive continuous improvement initiatives. Experience working in matrixed environments with internal and external partners.