Manager, QC Raw Materials
Emergent BioSolutions
June 29, 2026
On-site
Canton, MA
Operations
Job Summary
- Lead, develop, and manage the QC Raw Materials testing program at the Canton site. Maintain testing documentation/strategies and serve as SME for raw material issues with technical expertise aligned to GMP and industry practice.
- Ensure compliance to data integrity and quality systems (deviations, CAPAs, Change Controls, Effectiveness Checks, lab investigations) and provide training/mentoring for staff development.
Essential Functions
- Lead, manage, and professionally develop QC raw materials staff.
- Own raw material testing; assess compendial changes and drive revisions/new assay development per compendial and GxP requirements.
- Ensure lab staffing, training/cross-training, and operations meet internal/external cGMP compliance.
- Conduct equipment and method validation/verification; keep the lab current with compendial updates and implement timely changes.
- Review/approve technical and validation/verification protocols and reports.
- Lead OOS/OOT investigations and manage associated deviations, CAPAs, Change Controls, and Effectiveness Checks.
- Prioritize QC activities to meet timelines; interface with departments/sites; coordinate trending/testing data for QMR/Annual Product Review.
- Liaise with Regulatory Affairs for required documentation for submissions and change controls.
Minimum Education, Experience, Skills
- Bachelor’s or Advanced degree in Biology/Biochemistry or closely related field.
- 2+ years supervisory/leadership experience.
- Required: raw materials testing program knowledge; GLP/GMP (including cGMP), USP, FDA requirements; method/equipment validation/verification; assay method validation and analytical investigation (biotherapeutics/vaccines); Quality Systems experience (LIMS desired).
- Strong data evaluation, root-cause analysis, CAPA skills; knowledge of 21 CFR 210/211/600, USP-NF, aseptic processing; strong communication and ability to influence in a matrixed environment; independent work.
- Proficient in MS Office.
Benefits / Application Instructions
- Comprehensive benefits package (eligibility governed by plan documents).
- If selected for an interview, speak with an HR Partner about compensation philosophy and available benefits.
- Lead, develop, and manage the QC Raw Materials testing program at the Canton site. Maintain testing documentation/strategies and serve as SME for raw material issues with technical expertise aligned to GMP and industry practice.
- Ensure compliance to data integrity and quality systems (deviations, CAPAs, Change Controls, Effectiveness Checks, lab investigations) and provide training/mentoring for staff development.
Essential Functions
- Lead, manage, and professionally develop QC raw materials staff.
- Own raw material testing; assess compendial changes and drive revisions/new assay development per compendial and GxP requirements.
- Ensure lab staffing, training/cross-training, and operations meet internal/external cGMP compliance.
- Conduct equipment and method validation/verification; keep the lab current with compendial updates and implement timely changes.
- Review/approve technical and validation/verification protocols and reports.
- Lead OOS/OOT investigations and manage associated deviations, CAPAs, Change Controls, and Effectiveness Checks.
- Prioritize QC activities to meet timelines; interface with departments/sites; coordinate trending/testing data for QMR/Annual Product Review.
- Liaise with Regulatory Affairs for required documentation for submissions and change controls.
Minimum Education, Experience, Skills
- Bachelor’s or Advanced degree in Biology/Biochemistry or closely related field.
- 2+ years supervisory/leadership experience.
- Required: raw materials testing program knowledge; GLP/GMP (including cGMP), USP, FDA requirements; method/equipment validation/verification; assay method validation and analytical investigation (biotherapeutics/vaccines); Quality Systems experience (LIMS desired).
- Strong data evaluation, root-cause analysis, CAPA skills; knowledge of 21 CFR 210/211/600, USP-NF, aseptic processing; strong communication and ability to influence in a matrixed environment; independent work.
- Proficient in MS Office.
Benefits / Application Instructions
- Comprehensive benefits package (eligibility governed by plan documents).
- If selected for an interview, speak with an HR Partner about compensation philosophy and available benefits.