BioProcess Specialist
Emergent BioSolutions
August 14, 2026
On-site
Canton, MA
Operations
Job Summary
The Bioprocess Specialist is a senior individual contributor providing advanced technical and operational support to GMP vaccine drug substance manufacturing operations at the Canton, MA site. Serves as a manufacturing subject matter expert (SME) partnering with Manufacturing, Quality, MSAT, Engineering, and external stakeholders to ensure robust, compliant, and efficient bioprocess execution.
Essential Functions
- Provide hands-on technical leadership and GMP support for upstream, downstream, and/or bulk formulation processes.
- Lead/support complex investigations (process- and product-impacting deviations); author reports, root cause analyses, and ensure timely/effective CAPAs.
- Own/support Change Management: technical assessments, risk evaluations, implementation oversight, and change effectiveness verification.
- Drive process robustness and continuous improvement via data trending, RCA, risk assessments, and scientific principles.
- Collaborate cross-functionally (Manufacturing, Quality Assurance, MSAT, Validation, Supply Chain, Engineering) to resolve technical/compliance issues.
- Contribute to regulatory inspection readiness (document preparation, response development, participation in health authority inspections).
- Support process lifecycle activities (technology transfer, process characterization, process validation, ongoing process verification).
- Develop/maintain GMP documentation (SOPs, batch records, protocols, technical reports).
- Mentor staff on bioprocessing, GMP principles, and quality systems.
- Identify/implement best practices, digital tools, and operational excellence initiatives.
- Engage internal/external stakeholders (including vendors/partners) for troubleshooting and technical projects.
Minimum Education, Experience, Skills
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, Biology, or related field (Master’s preferred).
- 5–8 years of progressively responsible GMP biopharmaceutical manufacturing experience (strong preference: vaccine DS/biologics bulk).
- Expertise in GMP quality systems (deviations, CAPAs, change control, risk management, inspection readiness).
- Strong bioprocess unit operations knowledge; process control strategies; manufacturing science.
- Ability to lead/influence cross-functional teams in a matrixed organization.
- Experience authoring/reviewing GMP documentation, investigations, technical reports, and regulatory-facing content.
- Solid data analysis, problem-solving, and critical thinking with scientific/risk-based approaches.
- Excellent written/verbal communication skills.
- High accountability, sound judgment, quality mindset, and commitment to compliance/continuous improvement.
Application Instruction
If the hiring manager expresses interest in interviewing, discuss your interest with your current manager before an interview is scheduled.
The Bioprocess Specialist is a senior individual contributor providing advanced technical and operational support to GMP vaccine drug substance manufacturing operations at the Canton, MA site. Serves as a manufacturing subject matter expert (SME) partnering with Manufacturing, Quality, MSAT, Engineering, and external stakeholders to ensure robust, compliant, and efficient bioprocess execution.
Essential Functions
- Provide hands-on technical leadership and GMP support for upstream, downstream, and/or bulk formulation processes.
- Lead/support complex investigations (process- and product-impacting deviations); author reports, root cause analyses, and ensure timely/effective CAPAs.
- Own/support Change Management: technical assessments, risk evaluations, implementation oversight, and change effectiveness verification.
- Drive process robustness and continuous improvement via data trending, RCA, risk assessments, and scientific principles.
- Collaborate cross-functionally (Manufacturing, Quality Assurance, MSAT, Validation, Supply Chain, Engineering) to resolve technical/compliance issues.
- Contribute to regulatory inspection readiness (document preparation, response development, participation in health authority inspections).
- Support process lifecycle activities (technology transfer, process characterization, process validation, ongoing process verification).
- Develop/maintain GMP documentation (SOPs, batch records, protocols, technical reports).
- Mentor staff on bioprocessing, GMP principles, and quality systems.
- Identify/implement best practices, digital tools, and operational excellence initiatives.
- Engage internal/external stakeholders (including vendors/partners) for troubleshooting and technical projects.
Minimum Education, Experience, Skills
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, Biology, or related field (Master’s preferred).
- 5–8 years of progressively responsible GMP biopharmaceutical manufacturing experience (strong preference: vaccine DS/biologics bulk).
- Expertise in GMP quality systems (deviations, CAPAs, change control, risk management, inspection readiness).
- Strong bioprocess unit operations knowledge; process control strategies; manufacturing science.
- Ability to lead/influence cross-functional teams in a matrixed organization.
- Experience authoring/reviewing GMP documentation, investigations, technical reports, and regulatory-facing content.
- Solid data analysis, problem-solving, and critical thinking with scientific/risk-based approaches.
- Excellent written/verbal communication skills.
- High accountability, sound judgment, quality mindset, and commitment to compliance/continuous improvement.
Application Instruction
If the hiring manager expresses interest in interviewing, discuss your interest with your current manager before an interview is scheduled.