QC Microbiology Jobs at Syngene
A rare chance has emerged for professionals in QC Microbiology jobs at Syngene in Baltimore, MD. This position offers an opportunity to lead the Quality Control Microbiology team, ensuring compliance with regulatory standards while engaging in hands-on laboratory work.
About Syngene
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. With a strong team of over 4,240 scientists, Syngene collaborates with leading companies like Bristol-Myers Squibb and Amgen to solve scientific challenges. The organisation is committed to safety and quality, making it a prominent player in the biotech jobs sector.
Job Details:
- Date: 2 August 2026
- Location: Baltimore, MD, US, 21224
- Division: Manufacturing Services
- Job Title: Principal Specialist – Quality Control Microbiology Lead
- Reporting to: Head of Quality Control or Head of Quality
- Department: Quality Control
Job Description
The Principal Specialist – Quality Control Microbiology Lead will oversee the Microbiology functions within the QC unit at a large molecule manufacturing plant. This role is vital for aligning QC Microbiology operations with regulatory requirements and company objectives. The incumbent will lead the QC microbiology strategy, interface with clients, and collaborate across departments, ensuring timely analysis and inspection readiness. This position combines leadership with hands-on QC work, including sampling and testing.
Key Responsibilities
- Responsible for Quality Control (QC) Microbiology operations, ensuring compliance with Good Laboratory Practices (GLP) and regulatory requirements.
- Manage the Environmental Monitoring program, including drafting protocols and maintaining routine EM programs.
- Conduct routine microbiological tests on raw materials, intermediate and finished products, and facility utilities.
- Lead specialist in performing sampling and testing for microbiological tests.
- Draft and review the Contamination Control Strategy (CCS) and Disinfectant Efficacy Study.
- Coordinate with Quality Assurance (QA) for the development and transfer of microbiological tests.
- Ensure compliance with current pharmacopeial and regulatory requirements in QC test methods.
- Collaborate with the Biologics Process Development team to support drug substance development.
Eligibility Criteria
- Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required; Master’s degree is desired.
- Subject matter expert in Quality Control within biologics or pharmaceutical manufacturing environments.
- Understanding of USDA and USFDA, ICH, EU, and Health Canada regulations.
- Proven experience supporting regulatory inspections and third-party audits.
- Strong knowledge of biologic analytical techniques and method validation.
- Demonstrated ability to lead cross-functional teams and foster a culture of quality.
- Skilled in implementing robust quality systems and product lifecycle quality management.
- Experience in driving continuous improvement projects.
Required Skills
- Experience in bioanalytical and bioassay methods for biologic molecules.
- Ability to plan and manage resources for smooth operations in the QC microbiology lab.
Why Join Syngene?
Working at Syngene means being part of a vibrant and innovative environment where safety and quality are prioritised. The organisation offers Syngene careers that foster professional growth and development, allowing employees to contribute meaningfully to the advancement of the biotechnology and pharmaceutical sectors. The collaborative culture encourages continuous learning and improvement, making it an ideal place for those passionate about scientific excellence.
In summary, the Principal Specialist – Quality Control Microbiology position at Syngene presents an exceptional opportunity for professionals in QC microbiology jobs. This role not only allows for leadership in a critical area of quality control but also offers the chance to engage in hands-on laboratory work. Qualified candidates are encouraged to apply at the earliest to seize this opportunity in the thriving biotech sector.
