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.

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.