Principal Specialist – Quality Control Microbiology Lead

Syngene International Ltd., incorporated in 1993, 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. Our clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, and Merck KGaA. Our innovative culture is driven by the passion of our 4,240-strong team of scientists who work with clients globally to solve scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation. Safety is at the heart of everything we do, both personally and professionally.

About the role

The Principal Specialist – Quality Control Microbiology (QC Micro) Lead will serve as the Lead for the Microbiology side of the QC unit at a large molecule manufacturing plant in Baltimore, Maryland. This role is critical to ensuring QC Microbiology functions align with regulatory requirements, company objectives, and industry best practices. The incumbent will oversee the QC Microbiology team, lead the site’s microbiology strategy, 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 is a working Lead Specialist role, including hands-on QC work such as sampling and testing, as well as leading other analysts and specialists within the QC Microbiology group.

Responsibilities

• Oversee Quality Control (QC) Microbiology 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 the Environmental Monitoring (EM) program for the Baltimore site, including the Environmental Monitoring Process Qualification (EMPQ), such as drafting the protocol, executing the EMPQ, and completing the report, followed by designing and maintaining the routine EM program.
• Draft, execute, and complete reports for Water for Injection (WFI) qualification, followed by designing and maintaining the routine WFI program.
• Manage routine microbiological tests on raw materials, intermediate and finished products, and facility utilities such as water, gas, and environmental sampling.
• Serve as the lead specialist in performing routine sampling and testing for all microbiological tests, including utility, raw material, in-process and product, stability, and environmental monitoring.
• Draft, execute, and review/approve the Contamination Control Strategy (CCS).
• Draft, execute, and review/approve the Disinfectant Efficacy Study.
• Coordinate with Quality Assurance (QA) and other departments to ensure the development and transfer of microbiological tests and methods.
• Ensure qualification, validation, performance, and transfer of microbiology methods within the Biologics 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 Microbiological 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.
• Investigate laboratory incidents, out-of-specifications (OOS), deviations, out-of-trend (OOT) results, and client complaints related to QC testing, identifying root causes and implementing corrective and preventive actions (CAPA) in a timely manner.
• Ensure all documentation, including SOPs, IOPs, EOPs, and STPs, is periodically reviewed, updated, and maintained per the documentation control system.
• Ensure timely completion of QC activities as per project timelines and 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 preparation and timely closure of audit action plans and escalate concerns appropriately.
• Lead investigations and ensure closure of client and regulatory audit observations related to QC Microbiology.
• Ensure lab safety protocols are followed at all times and resolve technical issues in the QC Microbiology lab effectively.
• Support QC Microbiology in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
• Manage, coach, and develop the QC Microbiology team and contribute to their professional growth.
• Proactively monitor QC microbial trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required; Master’s degree is desired.
• Subject matter expertise in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products.
• Regulatory Knowledge: Understanding of USDA, USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards relevant to biologics manufacturing.
• Proven experience supporting regulatory inspections and third-party audits.
• Strong working knowledge of biologic analytical techniques and validation of methods.
• Demonstrated ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
• Skilled in implementing robust quality systems, qualifications, validations, and product lifecycle quality management.
• Track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality.

Skills

• Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.
• Ability to plan and manage resources for smooth operations in the QC microbiology lab.