Hiring: Principal Analytical Specialist Company: Syngene International Limited Location: Baltimore, MD Job Posted Time: 2026-09-03 11:15:55 Target Skills & Keywords : Quality Assurance, R About the job Experience: •8-12 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products. •12 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products. Required Skills: •Lead and oversee Quality Control (QC) Analytical operations, including product support for stability studies, raw material, microbiology lab and packing material testing, ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements. •Manage routine analytical tests on raw materials, on intermediate and finished products, and for facility utilities, such as water, gas, and environmental sampling. •Operate as the lead specialist in performing routine sampling and testing for all analytical tests, including for utility, raw material, in-process and product, and stability. •Coordinate with Quality Assurance (QA), and other departments to ensure development and transfer of analytical tests and methods. •Ensure qualification, validation, performance, and transfer of analytical methods within the QC department. •Interact with clients and project teams to ensure seamless execution of project-related activities. •Ensure all QC test methods, protocols, and technical reports related to Analytical operations comply with current pharmacopeial and regulatory requirements. •Partner cross-functionally with the Biologics Process Development team to plan and execute testing activities in support of drug substance development and manufacturing. Qualifications: •Regulatory Knowledge: Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards relevant to biologics manufacturing. •Audit Experience: Proven experience supporting regulatory inspections and third-party audits. •Technical Expertise: Strong working knowledge of biologic analytical techniques and validation of methods. •Leadership Skills: Demonstrated ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability. •Training & Development: Skilled in implementing robust quality systems, qualifications and validations and product lifecycle quality management. •Continuous Improvement: A track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality. •Plan and manage resources for smooth operations in the QC analytical lab. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!