Job Title: Principal Specialist - Quality Control Microbiology Lead
Reporting to: Head of Quality Control or Head of Quality
Department: Quality Control
Location: Baltimore, Maryland
Job Summary
The Principal Specialist - Quality Control Microbiology (QC Micro) Lead, will serve as the Lead for the Microbiology side of the QC unit at a large molecule manufacturing plant. This role is critical to ensuring that QC Microbiology functions are aligned with regulatory requirements, company objectives, and industry's best practices. The incumbent will be accountable for overseeing the QC Microbiology team, working under the Head of Quality Control or Head of Quality in Baltimore. The incumbent will lead the QC microbiology strategy for the site, interface with client counterparts, and partner cross-functionally with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure timely analysis and inspection readiness. This role is a working Lead Specialist role, and will include hands-on QC work, including sampling and testing, as well as being the lead of the other analysts and specialists within QC Microbiology group.
Primary Responsibilities
- Responsible for Quality Control (QC) Microbiology operations, including product support for stability studies, raw material, microbiology lab and packing material testing, ensuring compliance with Good Laboratory Practices (GLP) and applicable regulatory requirements.
- Manage the Environmental Monitoring program for the Bayview Baltimore site, including the Environmental Monitoring Process Qualification (EMPQ), such as drafting the protocol, execution of the EMPQ, and completing the report, followed by designing and maintaining the routine EM program. Draft protocol, execute, and complete report for WFI qualification, followed by designing and maintaining the routine WFI program.
- Manage routine microbiological tests on raw materials, on intermediate and finished products, and for facility utilities, such as water, gas, and environmental sampling.
- Operate as the lead specialist in performing routine sampling and testing for all microbiological tests, including for utility, raw material, in-process and product, stability, and environmental monitoring.
- Draft, execute, and review/approve the Contamination Control Strategy (CCS).
- Draft, execute, and review/approve the Disinfectant Efficacy Study.
- Coordinate with Quality Assurance (QA), and other departments to ensure development and transfer of microbiological tests and methods.
- Ensure qualification, validation, performance, and transfer of microbiology methods within the Biologics department.
- Interact with clients and project teams to ensure seamless execution of project-related activities.
- Ensure all QC test methods, protocols, and technical reports related to Microbiological operations comply with current pharmacopeial and regulatory requirements.
- 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.
- Establish functional working teams for self-assessment of compliance to SOPs and data integrity standards.
- Ensure preparation and timely closure of audit action plans and escalate concerns appropriately.
- Lead investigations and ensure 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 in regulatory filings, including Prior Approval Submissions, renewals, updates, and supplements, as required.
- Manage, coach, and develop the QC Microbiology team and contribute to their professional growth.
- Proactively monitor QC microbial 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; Master's degree is desired.
- Subject matter expert 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: Proven experience supporting regulatory inspections and third-party audits.
- 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 bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.
- Plan and manage resources for smooth operations in the QC microbiology lab.
