Principal Scientist– Quality Control Microbiology Lead

Job Title: Principal Specialist Quality Control Microbiology Lead

Reporting to: Head of Quality Control or Head of Quality

Department: Quality Control

Location: Baltimore Maryland

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 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.

Job Summary

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. This role is critical to ensuring that QC Microbiology functions are aligned with regulatory requirements company objectives and industrys best practices. The incumbent will be accountable for overseeing the QC Microbiology team working under the Head of Quality Control or Head of Quality in Baltimore. The incumbent will lead the QC microbiology 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 Microbiology group.

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Primary Responsibilities

• Responsible for 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 program for the Bayview Baltimore site including the Environmental Monitoring Process Qualification (EMPQ) such as drafting the protocol execution of the EMPQ and completing the report followed by designing and maintaining the routine EM program. Draft protocol execute and complete report for WFI qualification followed by designing and maintaining the routine WFI program.
• Manage routine microbiological 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 microbiological tests including for 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 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.
• 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 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.

Education & Qualifications

• Education: Bachelors degree in Chemistry Biochemistry Chemical Engineering or a related scientific discipline is required; Masters degree is desired.
• Subject matter expert in Quality Control within biologics or pharmaceutical manufacturing environments specifically for large molecule products.
• 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.

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.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age colour national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.