BioProcess Specialist

Emergent Biosolutions•Canton, MA

1d•$111,000 - $134,400•Onsite

About The Position

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 bioproprocess 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.

Requirements

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.

Nice To Haves

Master’s degree is preferred.

Responsibilities

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.