Lead Scientist, AS&T
Emergent BioSolutions
June 25, 2026
On-site
Canton, MA
Operations
Job Summary
The Lead Scientist, AS&T supporting QC Method Lifecycle Development provides leadership and oversight for QC method development/transfer, qualification, verification/validation, QC equipment qualification/administration, method performance review and data trending, QC reference standards/controls management, and QC projects/investigations. SME support at the Canton site and maintenance of compliant test methods/instruments.
Essential Functions
- Oversee and manage QC activities for development, transfer, qualification, verification, and validation of test methods; draft/review/approve protocols and reports with internal/external clients; create timelines and schedules.
- Provide technical expertise for method development/optimization, verification, qualification, and validation (analyze/interprete data; investigate analytical problems; collaborate on corrective approaches).
- Ensure QC equipment compliance to USP and 21 CFR Part 11; serve as site administrator for QC equipment and LIMS.
- Interact with auditors and agency representatives; present to senior management on goals, budget, and functional-area operations.
- Prepare/oversee cGMP methods, protocols, trend reports/summaries; update schedules and presentations; participate in senior staff meetings.
- Review lab practices to identify improvement strategies/cost savings.
- Provide scientific review/approval of protocols, reports, study design, and SOPs.
- Conduct managerial duties (resource management; failure investigation review) as assigned.
- Investigate/troubleshoot deviations and CAPAs; provide SME support.
Minimum Education/Experience/Skills
- BS with 10+ years relevant experience or MS with 8+ years.
- 5+ years prior management experience.
- Expertise in immunological, bioanalytical, and chemical test methods (e.g., ELISA, qPCR, IEF, viral/cell-based assays, SDS-PAGE, Western blot, DNA sequencing, sterility, endotoxin, HPLC, CE, UV/IR spectroscopy).
- Advanced knowledge of USP/EP, cGMPs, 21 CFR Part 11, and data integrity.
- Experience with phase-appropriate method qualifications/validations; assay/equipment validation; analytical investigations for biotherapeutic/vaccine products.
- Ability to apply statistics to QC monitoring/trending.
Application Instruction
- If interested in interviewing, discuss your interest with your current manager before an interview is scheduled.
Compensation/Benefits (if applicable)
- Estimated base salary range: $150,000–$176,000; eligibility for additional incentive compensation and a comprehensive benefits package.
The Lead Scientist, AS&T supporting QC Method Lifecycle Development provides leadership and oversight for QC method development/transfer, qualification, verification/validation, QC equipment qualification/administration, method performance review and data trending, QC reference standards/controls management, and QC projects/investigations. SME support at the Canton site and maintenance of compliant test methods/instruments.
Essential Functions
- Oversee and manage QC activities for development, transfer, qualification, verification, and validation of test methods; draft/review/approve protocols and reports with internal/external clients; create timelines and schedules.
- Provide technical expertise for method development/optimization, verification, qualification, and validation (analyze/interprete data; investigate analytical problems; collaborate on corrective approaches).
- Ensure QC equipment compliance to USP and 21 CFR Part 11; serve as site administrator for QC equipment and LIMS.
- Interact with auditors and agency representatives; present to senior management on goals, budget, and functional-area operations.
- Prepare/oversee cGMP methods, protocols, trend reports/summaries; update schedules and presentations; participate in senior staff meetings.
- Review lab practices to identify improvement strategies/cost savings.
- Provide scientific review/approval of protocols, reports, study design, and SOPs.
- Conduct managerial duties (resource management; failure investigation review) as assigned.
- Investigate/troubleshoot deviations and CAPAs; provide SME support.
Minimum Education/Experience/Skills
- BS with 10+ years relevant experience or MS with 8+ years.
- 5+ years prior management experience.
- Expertise in immunological, bioanalytical, and chemical test methods (e.g., ELISA, qPCR, IEF, viral/cell-based assays, SDS-PAGE, Western blot, DNA sequencing, sterility, endotoxin, HPLC, CE, UV/IR spectroscopy).
- Advanced knowledge of USP/EP, cGMPs, 21 CFR Part 11, and data integrity.
- Experience with phase-appropriate method qualifications/validations; assay/equipment validation; analytical investigations for biotherapeutic/vaccine products.
- Ability to apply statistics to QC monitoring/trending.
Application Instruction
- If interested in interviewing, discuss your interest with your current manager before an interview is scheduled.
Compensation/Benefits (if applicable)
- Estimated base salary range: $150,000–$176,000; eligibility for additional incentive compensation and a comprehensive benefits package.