BioProcess Specialist

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. This role serves as a manufacturing subject matter expert (SME), partnering closely with Manufacturing, Quality, MSAT, Engineering, and external stakeholders to ensure robust, compliant, and efficient bioprocess execution. The incumbent plays a critical role in process performance monitoring, QMS execution (deviations, CAPAs, change control), continuous improvement, and regulatory readiness, with a strong focus on product quality, patient safety, and inspection success.

ESSENTIAL FUNCTIONS

• Provide hands-on technical leadership and GMP support to vaccine drug substance manufacturing operations, acting as a trusted SME for upstream, downstream, and/or bulk formulation processes.
• Lead and support complex investigations (process- and product-impacting deviations), author high-quality investigation reports, root cause analyses, and ensure timely, effective, and sustainable CAPAs.
• Own and support Change Management activities, including technical assessments, risk evaluations, implementation oversight, and change effectiveness verification.
• Drive process robustness and continuous improvement through data trending, root cause analysis, risk assessments, and application of process understanding and scientific principles.
• Collaborate cross-functionally with Manufacturing, Quality Assurance, MSAT, Validation, Supply Chain, and Engineering to resolve complex technical and compliance issues.
• Serve as a key contributor to regulatory inspection readiness activities, including document preparation, response development, and participation in health authority inspections.
• Support process lifecycle activities including technology transfer, process characterization, process validation, and ongoing process verification, as applicable to a GMP vaccine DS site.
• Develop and maintain GMP documentation, including SOPs, batch records, protocols, and technical reports, ensuring accuracy, clarity, and compliance with regulatory expectations.
• Mentor manufacturing and technical staff by sharing expertise in bioprocessing, GMP principles, and quality systems, enhancing organizational capability and knowledge depth.
• Identify, implement, and sustain best practices, digital tools, and operational excellence initiatives aligned with site and network strategies.
• Engage internal and external stakeholders, including vendors and partners, to support troubleshooting, continuous improvement, and execution of technical projects.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, Biology, or a related scientific discipline is required; Master’s degree is preferred.
• Minimum of 5–8 years of progressively responsible experience in GMP biopharmaceutical manufacturing, with strong preference for vaccine drug substance or biologics bulk manufacturing.
• Demonstrated expertise in GMP quality systems, including deviations, CAPAs, change control, risk management, and inspection readiness.
• Strong technical understanding of bioprocess unit operations (upstream and/or downstream), process control strategies, and manufacturing science.
• Proven ability to lead and influence cross-functional teams without direct authority in a matrixed organization.
• Experience authoring and reviewing GMP documentation, investigations, technical reports, and regulatory-facing content.
• Solid data analysis, problem-solving, and critical thinking skills, with the ability to apply scientific and risk-based approaches to complex issues.
• Excellent written and verbal communication skills, with the ability to present technical information clearly to diverse audiences.
• High level of accountability, sound judgment, and quality mindset, with a demonstrated commitment to compliance and continuous improvement.