Title:  Lead-Quality Control

Job Title: Lead-Quality Control

Reporting to:  Head of Quality

Department: Quality

Location: Baltimore, Maryland

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organisation providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and speciality 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 Team Lead Quality Control (QC)  serve as operational oversight for the QC unit at a large molecule manufacturing plant. This role is critical to ensuring that all QC functions are aligned with regulatory requirements, company objectives, and industry’s best practices. The incumbent will be accountable for overseeing QC and Microbiology team, Compliance, Validation, and Documentation, working along with the Head of Quality Control in Baltimore. The incumbent will lead the QC strategy for the site, interface with regulatory authorities, and partner cross-functionally with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness.

.

Primary Responsibilities

• Ensure qualification, validation and performance within the facility.
• Coordinate with instrument vendors for preventive maintenance, calibration, and repairs.
• Ensure all analytical instruments are calibrated as per the established procedures and defined frequencies.
• Ensure all QC test methods, protocols, and technical reports comply with current pharmacopeial and regulatory requirements.
• Ensure all documentation, including SOPs, IOPs, EOPs, and STPs, is periodically reviewed, updated, and maintained as per the documentation control system.
• Actively participate in functional and cross-functional teams to ensure Biologics product testing is conducted in compliance with current Good Manufacturing Practices (cGMP).
• Adhere to ALCOA principles of data integrity for self and ensure compliance by team members.
• Ensure lab safety protocols are followed at all times and resolve technical issues in the QC Biologics lab effectively.
• Ensure that laboratory incidents, OOS, deviations, and OOT results are thoroughly investigated, root causes identified, and CAPA implemented.
• Ensure timely completion of QC activities as per project timelines. Update work plans periodically to accommodate changes in scope or priorities.
• Coordinate with Quality Assurance (QA), and other departments to ensure smooth transfer of new analytical methods.

Education & Qualifications

• Education: Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required; Master’s degree is preferred.
• Experience: 10-15 years of progressively responsible experience in Quality Control within biologics or pharmaceutical manufacturing environments, specifically for large molecule products.
• Regulatory Knowledge: Deep 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 managing regulatory inspections and third-party audits with successful outcomes.
• 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 chromatography, bioanalytical, and bioassay methods for monoclonal antibodies and other biologic molecules.
• Overall responsible for Quality Control operations, including product support, microbiology lab, stability studies, and testing of raw and packaging materials; ensure compliance with Good Laboratory Practices (GLP) and other regulatory requirements.
• Plan and manage resources for smooth operations in the QC Biologics (QCB) lab.
• Ensure timely release of finished products, intermediate products, stability samples, and raw materials within the assigned turnaround time (TAT).
• Interact with clients and project teams to ensure smooth execution of project-related activities.
• Manage, coach, and develop the QC Biologics team; provide direction and monitor team activities to drive excellence and support team growth.

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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.