Job summary
Job post source
This job is directly from Syngene International Limited
Job overview
The Lead-Quality Control at Syngene International Limited oversees QC operations at a large molecule manufacturing plant, ensuring compliance with regulatory standards and driving quality control strategy.
Responsibilities and impact
The role involves managing QC and Microbiology teams, ensuring instrument calibration and validation, maintaining documentation, investigating lab incidents, coordinating with QA and other departments, and ensuring timely QC activities.
Experience and skills
Requires 10-15 years in Quality Control within biologics or pharmaceutical manufacturing, strong regulatory knowledge (USDA, USFDA, ICH, EU, Health Canada), audit experience, technical expertise in biologic analytical techniques, leadership skills, and continuous improvement experience.
Work environment and culture
Syngene values safety highly, fosters a culture of quality, compliance, and accountability, and emphasizes equal opportunity and accommodations for disabilities.
Company information
Syngene International Limited is a global discovery, development and manufacturing organization founded in 1993, serving pharmaceutical, biotechnology, and other industries with a 4240-strong scientific team and notable clients like Bristol-Myers Squibb and Amgen.
Team overview
The candidate will lead the QC and Microbiology teams, working closely with the Head of Quality Control and cross-functional departments.
Job location and travel
The position is based in Baltimore, Maryland, United States.
Unique job features
The role includes leadership of QC strategy, interface with regulatory authorities, and responsibility for compliance with cGMP and data integrity principles.
Company overview
Syngene International Limited is a leading contract research, development, and manufacturing organization based in India, serving global pharmaceutical, biotechnology, and agrochemical companies. The company generates revenue by providing integrated discovery, development, and manufacturing services across small molecules, biologics, and specialty chemicals, supporting clients from early-stage research to commercial supply. Established in 1993 as a subsidiary of Biocon Limited, Syngene has grown through strategic partnerships with major clients like Bristol Myers Squibb and Amgen, and operates state-of-the-art research facilities in Bengaluru. Its reputation for scientific innovation, regulatory compliance, and scalable solutions has positioned it as a trusted partner for multinational corporations seeking to accelerate product development. Candidates should be aware of Syngene’s commitment to quality, safety, and sustainability, as well as its significant role in advancing global healthcare and life sciences.
How to land this job
Tailor your resume to emphasize extensive experience in Quality Control within biologics or pharmaceutical manufacturing, highlighting leadership in managing QC teams and cross-functional collaboration.
Focus on showcasing your deep regulatory knowledge of USDA, USFDA, ICH, EU, Health Canada, and pharmacopeial standards, as well as your expertise in biologic analytical techniques and method validation.
Apply through Syngene International Limited's corporate careers site, LinkedIn, and other job portals where the position is listed to maximize your application visibility.
Connect on LinkedIn with professionals in Syngene's Quality department or Biologics division; start conversations by commenting on recent company achievements or asking about the team culture and current challenges in QC.
Optimize your resume for ATS by including keywords such as 'Quality Control,' 'cGMP,' 'biologics manufacturing,' 'method validation,' 'regulatory compliance,' and 'CAPA investigation' to ensure it passes initial automated screenings.
Leverage Jennie Johnson's Power Apply feature to automate tailored resume customization, multi-channel applications, and LinkedIn networking outreach, freeing you to focus on interview preparation and skill enhancement.
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