BioProcess Specialist
Emergent BioSolutions
June 24, 2026
On-site
Canton, MA
Operations
Job Summary
The Bioprocess Specialist provides advanced technical and operational support to GMP vaccine drug substance manufacturing at the Canton, MA site as a manufacturing subject matter expert (SME).
Essential Functions / Responsibilities
- Provide hands-on technical leadership and GMP support for upstream/downstream/bulk formulation processes.
- Lead/support complex investigations (deviations), author reports and root cause analyses, and ensure timely CAPAs.
- Own/support Change Management (technical assessments, risk evaluations, implementation oversight, change effectiveness verification).
- Drive process robustness and continuous improvement via data trending, root cause analysis, risk assessments, and scientific approaches.
- Collaborate cross-functionally to resolve complex technical and compliance issues.
- Support regulatory inspection readiness (document preparation, response development, health authority inspection participation).
- Support process lifecycle activities (technology transfer, process characterization, validation, ongoing process verification).
- Develop/maintain GMP documentation (SOPs, batch records, protocols, technical reports).
- Mentor staff in bioprocessing, GMP principles, and quality systems.
- Identify/implement best practices, digital tools, and operational excellence initiatives.
- Engage internal/external stakeholders (vendors/partners) for troubleshooting and technical projects.
Minimum Education, Experience, Skills
- Bachelor’s degree in a relevant scientific discipline (Master’s preferred).
- 5–8 years GMP biopharmaceutical manufacturing experience; strong preference for vaccine drug substance/biologics bulk.
- GMP quality system expertise (deviations, CAPAs, change control, risk management, inspection readiness).
- Strong knowledge of bioprocess unit operations and process control/manufacturing science.
- Ability to lead/influence cross-functional teams in a matrix.
- Experience authoring/reviewing GMP documentation, investigations, and regulatory-facing content.
- Data analysis, problem-solving, and scientific/risk-based thinking.
- Excellent written/verbal communication.
- Accountability, judgment, quality mindset, compliance and continuous improvement.
Benefits / Application Instructions
- Base salary range (new hire): $111,000–$134,400; eligibility for additional incentive compensation where applicable.
- Comprehensive benefits package available.
- Before scheduling an interview, discuss interest in the role with your current manager.
The Bioprocess Specialist provides advanced technical and operational support to GMP vaccine drug substance manufacturing at the Canton, MA site as a manufacturing subject matter expert (SME).
Essential Functions / Responsibilities
- Provide hands-on technical leadership and GMP support for upstream/downstream/bulk formulation processes.
- Lead/support complex investigations (deviations), author reports and root cause analyses, and ensure timely CAPAs.
- Own/support Change Management (technical assessments, risk evaluations, implementation oversight, change effectiveness verification).
- Drive process robustness and continuous improvement via data trending, root cause analysis, risk assessments, and scientific approaches.
- Collaborate cross-functionally to resolve complex technical and compliance issues.
- Support regulatory inspection readiness (document preparation, response development, health authority inspection participation).
- Support process lifecycle activities (technology transfer, process characterization, validation, ongoing process verification).
- Develop/maintain GMP documentation (SOPs, batch records, protocols, technical reports).
- Mentor staff in bioprocessing, GMP principles, and quality systems.
- Identify/implement best practices, digital tools, and operational excellence initiatives.
- Engage internal/external stakeholders (vendors/partners) for troubleshooting and technical projects.
Minimum Education, Experience, Skills
- Bachelor’s degree in a relevant scientific discipline (Master’s preferred).
- 5–8 years GMP biopharmaceutical manufacturing experience; strong preference for vaccine drug substance/biologics bulk.
- GMP quality system expertise (deviations, CAPAs, change control, risk management, inspection readiness).
- Strong knowledge of bioprocess unit operations and process control/manufacturing science.
- Ability to lead/influence cross-functional teams in a matrix.
- Experience authoring/reviewing GMP documentation, investigations, and regulatory-facing content.
- Data analysis, problem-solving, and scientific/risk-based thinking.
- Excellent written/verbal communication.
- Accountability, judgment, quality mindset, compliance and continuous improvement.
Benefits / Application Instructions
- Base salary range (new hire): $111,000–$134,400; eligibility for additional incentive compensation where applicable.
- Comprehensive benefits package available.
- Before scheduling an interview, discuss interest in the role with your current manager.