BioProcess Specialist

 Preparedness today, safer tomorrow.

 Emergent is a leading public health company that delivers protective and life-saving solutions to
 communities around the world.  Here, you will join passionate professionals where our culture is informed
 by our values and commitment to protecting and saving lives.

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

 

Reasonable accommodations will be made to enable individuals with disabilities to perform the 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.

 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

 

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

 

• 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