Principal Analytical Specialist

Job Title: Principal Specialist – Quality Control Analytical Lead

Reporting to: Head of Quality Control or Head of Quality

Department: Quality Control

Location: Baltimore, Maryland

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, and Merck KGaA. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

The Principal Specialist – Quality Control Analytical (QC Analytical) Lead, will serve as the Lead for the Microbiology side of the QC unit at a large molecule manufacturing plant. This role is critical to ensuring that QC Analytical functions are aligned with regulatory requirements, company objectives, and industry’s best practices. The incumbent will be accountable for overseeing the QC Analytical team, working under the Head of Quality Control or Head of Quality in Baltimore.

The incumbent will lead the QC Analytical strategy for the site, interface with client counterparts, and partner cross-functionally with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. This role is a working Lead Specialist role, and will include hands‑on QC work, including sampling and testing, as well as being the lead of the other analysts and specialists within QC Analytical group.

• Responsible for 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.
• Collaborate with the Biologics Process Development team to plan and execute testing activities in support of drug substance development and manufacturing.
• Ensure that laboratory incidents, out‑of‑specifications (OOS), deviations, out‑of‑trend (OOT) results, and client complaints related to QC testing are thoroughly investigated, root causes identified, and corrective and preventive actions (CAPA) implemented in a timely manner.
• Ensure all documentation, including SOPs, IOPs, EOPs, and STPs, is periodically reviewed, updated, and maintained as per the documentation control system.
• Ensure timely completion of QC activities as per project timelines. Update work plans periodically to accommodate changes in project scope, priorities, or timelines.
• Adhere to ALCOA principles of data integrity for self and ensure compliance by team members.
• Establish functional working teams for self‑assessment of compliance to SOPs and data integrity standards.
• Ensure…