Sr Manager, QC Microbiology
Emergent BioSolutions
June 25, 2026
On-site
Canton, MA
Operations
Job Summary
The Senior Manager, QC Microbiology will lead, develop, and direct the QC Microbiology and Sterility Assurance programs at the site, including documentation, testing strategies, and subject matter expertise aligned with current GMPs and industry practice. Responsible for EMPQ and Quarterly/Annual EM/Utility Monitoring reports.
Essential Functions
- Lead, manage, and professionally develop all staff members.
- Oversee EMPQ, Cleaning/Disinfection studies, and ensure a compliant site EM/Utility monitoring program.
- Manage the Environmental Monitoring Program; prepare quarterly/annual trend reports and recommend continuous improvements.
- Accountable for testing of raw materials, utilities/environmental monitoring, and in-process/final product samples.
- Ensure QC laboratory staffing and training to meet internal/external (cGMP) requirements.
- Manage the sterility assurance program to ensure product quality and adherence to GMPs, ICH/FDA guidance, Annex 1, local procedures, and global standards.
- Stay current with compendia changes; implement updates in a timely manner.
- Review/approve technical protocols and reports.
- Review/approve OOS/OOT investigations and deviations.
- Manage QC activities and prioritize to meet site/project timelines.
- Interface with departments/sites on projects and quality issues.
- Coordinate data for Quality Management Review and Annual Product Review.
- Liaise with Regulatory Affairs; prepare/review regulatory submission and change control documentation.
Minimum Education/Experience/Skills
- Bachelor’s in Microbiology/Biology/Chemistry or related field; Master’s preferred.
- 8+ years vaccine/biopharmaceutical experience with aseptic processing; 5+ years supervisory/leadership.
- Required: Sterility Assurance knowledge; GMPs and FDA requirements; cGMP knowledge across QC.
- Experience with cGMPs/21CFR210/211/600, USP-NF, and Aseptic Processing Guidelines.
- Proficiency in MS Office; ability to critically evaluate data summaries/conclusions.
- Team player; influence without authority; excellent verbal/written interpersonal skills.
Compensation/Benefits (if selected)
- Estimated base salary: $171,500–$207,500 annually.
- Comprehensive benefits package (eligibility governed by plan documents/policies).
Application Instructions
- If interested in interviewing, discuss interest with your current manager before the interview is scheduled.
The Senior Manager, QC Microbiology will lead, develop, and direct the QC Microbiology and Sterility Assurance programs at the site, including documentation, testing strategies, and subject matter expertise aligned with current GMPs and industry practice. Responsible for EMPQ and Quarterly/Annual EM/Utility Monitoring reports.
Essential Functions
- Lead, manage, and professionally develop all staff members.
- Oversee EMPQ, Cleaning/Disinfection studies, and ensure a compliant site EM/Utility monitoring program.
- Manage the Environmental Monitoring Program; prepare quarterly/annual trend reports and recommend continuous improvements.
- Accountable for testing of raw materials, utilities/environmental monitoring, and in-process/final product samples.
- Ensure QC laboratory staffing and training to meet internal/external (cGMP) requirements.
- Manage the sterility assurance program to ensure product quality and adherence to GMPs, ICH/FDA guidance, Annex 1, local procedures, and global standards.
- Stay current with compendia changes; implement updates in a timely manner.
- Review/approve technical protocols and reports.
- Review/approve OOS/OOT investigations and deviations.
- Manage QC activities and prioritize to meet site/project timelines.
- Interface with departments/sites on projects and quality issues.
- Coordinate data for Quality Management Review and Annual Product Review.
- Liaise with Regulatory Affairs; prepare/review regulatory submission and change control documentation.
Minimum Education/Experience/Skills
- Bachelor’s in Microbiology/Biology/Chemistry or related field; Master’s preferred.
- 8+ years vaccine/biopharmaceutical experience with aseptic processing; 5+ years supervisory/leadership.
- Required: Sterility Assurance knowledge; GMPs and FDA requirements; cGMP knowledge across QC.
- Experience with cGMPs/21CFR210/211/600, USP-NF, and Aseptic Processing Guidelines.
- Proficiency in MS Office; ability to critically evaluate data summaries/conclusions.
- Team player; influence without authority; excellent verbal/written interpersonal skills.
Compensation/Benefits (if selected)
- Estimated base salary: $171,500–$207,500 annually.
- Comprehensive benefits package (eligibility governed by plan documents/policies).
Application Instructions
- If interested in interviewing, discuss interest with your current manager before the interview is scheduled.