Specialist QC Microbiology

Initial Therapeutics, Inc.; Baltimore (MD); On-site; USD 100,000 - 140,000; Full time

Job summary

Syngene International Ltd. seeks a Specialist in Quality Control Microbiology to perform routine sampling and testing, support method transfer, and ensure GLP-compliant operations at a large molecule manufacturing site in Baltimore, MD.

The role collaborates with QA, Manufacturing, Regulatory, and Supply Chain to ensure timely analysis and inspection readiness. The candidate will validate and transfer microbiology methods, investigate deviations, and drive CAPAs, aiming for continuous

Qualifications

• Experience in QC within biologics/pharmaceutical manufacturing.
• Understanding of USDA, USFDA, ICH, EU and Health Canada regulations.
• Audit experience with regulatory inspections and third-party audits.
• Knowledge of biologic techniques and method validation.

Responsibilities

• Perform routine QC microbiology sampling and testing for materials, processes and stability.
• Support development and transfer of microbiology tests and methods.
• Ensure GLP compliance and regulatory documentation is accurate and timely.
• Investigate deviations, OOS/OOT results and CAPAs with root-cause analysis.

Skills

Quality control

Regulatory compliance

Cross-functional collaboration

Leadership

Problem solving

Education

Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or related

Job description

Job Title: Specialist – Quality Control Microbiology

Reporting to: Head of Quality Control Microbiology

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 Specialist – Quality Control Microbiology (QC Microbiology), will serve as an analyst/specialist for the Microbiology side of the QC unit at a large molecule manufacturing plant. The incumbent will work within the QC Microbiology group for the site and partner cross-functionally with QC Analytical, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. This role is a working Specialist role, and will include hands‑on QC work, including sampling and testing, as well as working with analysts and specialists within QC Microbiology group to develop, qualify/validate, and transfer methods.

Primary Responsibilities

• Responsible for working in Quality Control (QC) Microbiology operations, including product support for stability studies, raw material, ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements.
• Operate as the specialist in performing routine sampling and testing for all Microbiology tests, including for utility, raw material, in-process and product, and stability.
• Coordinate with Quality Assurance (QA), and other departments to ensure development and transfer of microbiology tests and methods.
• Ensure qualification, validation, performance, and transfer of Microbiology methods within the QC department.
• Interact with clients and project teams to ensure seamless execution of project-related activities.
• 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.
• Participate in functional working teams for self-assessment of compliance to SOPs and data integrity standards.
• Support preparation and timely closure of audit action plans and elevate concerns appropriately.
• Support investigations and 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 documentation in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
• Support monitoring of QC microbiology trends, complaints, failures, deviations, and changes to identify opportunities for process, system, and product improvements.

Education & Qualifications

• Education: Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required;
• Experience: 5-8 years of progressively responsible experience 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: Experience supporting regulatory inspections and third-party audits.
• Technical Expertise: Working knowledge of biologic techniques and validation of methods.
• Leadership Skills: Ability to lead cross-functional teams, build relationships across departments, and foster a culture of quality, compliance, and accountability.
• Training & Development: Experience working within 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.