Specialist QC Microbiology

About Syngene

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 4,240-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, with shared responsibility and accountability including following safety guidelines, procedures and SOPs in letter and spirit.

About the role

The Specialist – Quality Control Microbiology (QC Microbiology) will serve as an analyst/specialist for the Microbiology side of the QC unit at a large molecule manufacturing plant. The incumbent will work within the QC Microbiology group for the site and partner cross-functionally with QC Analytical, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. This role is a working Specialist role and will include hands-on QC work, including sampling and testing, as well as working with analysts and specialists within the QC Microbiology group to develop, qualify/validate, and transfer methods.

Responsibilities

• Perform routine sampling and testing for all Microbiology tests, including for utility, raw material, in-process and product, and stability.
• Support product stability studies and raw material testing while ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements.
• Coordinate with Quality Assurance (QA) and other departments to ensure development and transfer of microbiology tests and methods.
• Ensure qualification, validation, performance, and transfer of Microbiology methods within the QC department.
• Interact with clients and project teams to ensure seamless execution of project-related activities.
• Collaborate with the Biologics Process Development team to plan and execute testing activities in support of drug substance development and manufacturing.
• Thoroughly investigate laboratory incidents, out-of-specifications (OOS), deviations, out-of-trend (OOT) results, and client complaints related to QC testing; identify root causes and implement corrective and preventive actions (CAPA) in a timely manner.
• Maintain and periodically review documentation, including SOPs, IOPs, EOPs, and STPs, as per the documentation control system.
• Ensure timely completion of QC activities as per project timelines and update work plans to accommodate changes in project scope, priorities, or timelines.
• Adhere to ALCOA principles of data integrity for self and ensure compliance by team members.
• Participate in functional working teams for self-assessment of compliance to SOPs and data integrity standards.
• Support preparation and timely closure of audit action plans and escalate concerns appropriately.
• Support investigations and 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 documentation in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
• Support monitoring of QC microbiology trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.

Education & Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required.
• 5–8 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products.
• Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards relevant to biologics manufacturing.
• Experience supporting regulatory inspections and third-party audits.
• Working knowledge of biologic techniques and validation of methods.
• Ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
• Experience working within quality systems, qualifications and validations and product lifecycle quality management.
• A track record of driving successful continuous improvement projects to enhance efficiency, reduce deviations, and increase product quality.

Additional Competencies

• Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.
• Plan and manage resources for smooth operations in the QC Microbiology lab.