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Increase your chances of reaching the interview stage by reading the complete job description and applying promptly. Get AI-powered advice on this job and more exclusive features. 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 worldwide. Syngene’s clientele includes Bristol-Myers Squibb, Baxter, Amgen, GSK, and Merck KGaA. Its innovative culture is driven by a team of 4,240 scientists dedicated to solving scientific problems, improving R&D productivity, speeding time to market, and lowering innovation costs. Job Title: Lead-Quality Control Reporting to: Head of Quality Department: Quality Location: Baltimore, Maryland Job Summary: The Team Lead for Quality Control (QC) oversees operations at a large molecule manufacturing plant, ensuring compliance with regulatory requirements, company standards, and industry best practices. Responsibilities include managing QC and Microbiology teams, compliance, validation, and documentation, collaborating with the Head of Quality Control, interfacing with regulatory bodies, and partnering with Manufacturing, QA, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. Primary Responsibilities: Ensure qualification, validation, and performance within the facility. Coordinate preventive maintenance, calibration, and repairs with instrument vendors. Maintain calibration of analytical instruments as per procedures and schedules. Ensure compliance of all test methods, protocols, and reports with regulatory standards. Review and update SOPs, IOPs, EOPs, and STPs regularly. Participate in cross-functional teams to ensure cGMP compliance in biologics testing. Uphold data integrity principles (ALCOA) across the team. Enforce lab safety protocols and resolve technical issues effectively. Investigate incidents, OOS, deviations, and OOT results; implement CAPA. Complete QC activities timely and update work plans as needed. Coordinate with QA and other departments for method transfer. Qualifications: Bachelor’s in Chemistry, Biochemistry, Chemical Engineering, or related; Master’s preferred. 10-15 years in QC within biologics/pharmaceutical manufacturing. Deep knowledge of USDA, USFDA, ICH, EU, Health Canada regulations, USP standards. Experience managing regulatory inspections and audits. Strong knowledge of biologic analytical techniques and validation. Leadership skills to manage cross-functional teams and foster quality culture. Experience in implementing quality systems, qualifications, validations, and product lifecycle management. Proven track record in continuous improvement projects. Additional Competencies: Experience with chromatography, bioanalytical, and bioassay methods for biologics. Responsible for QC operations including microbiology, stability, and raw material testing, ensuring GLP compliance. Resource planning for QC biologics labs. Ensure timely release of products and materials. Interact with clients and project teams for smooth project execution. Manage, coach, and develop QC team members. Equal Opportunity Employer: Syngene is committed to providing equal employment opportunities to all persons regardless of age, color, national origin, disability, race, religion, gender, sexual orientation, gender identity/expression, genetic information, marital status, veteran status, or any characteristic protected by law. Reasonable accommodations will be provided for qualified individuals with disabilities. Seniority level Director Employment type Full-time Job function Quality Assurance

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