BioProcess Engineering Lead — Tech Transfer & MS&T

Emergent BioSolutions; Canton (CO); On-site; USD 129,000 - 156,000; Full time

Job summary

Emergent BioSolutions in Canton, CO is seeking a Senior BioProcess Engineer to provide technical leadership on development, manufacturing, and tech transfer projects. You will plan, coordinate, communicate, and summarize programs, applying CGMP experience to ensure processes are capable, compliant, in control, and cost‑effective.

The role features MSAT leadership across process development, transfer, and continued verification, with responsibilities that include supporting manufacturing

Qualifications

• BS, MS, or PhD in Science or Engineering with a minimum of (BS+8yrs) /(MS+6yrs)/ (PhD+4yrs) of relevant job experience in biopharma or pharmaceutical industry
• The Senior BioProcess Engineer should have solid technical leadership in several functional areas and in-depth CGMP experience with vaccines/biologics manufacturing science and technology.
• Experience working under a Quality Management System.
• Ability to manage multiple priorities and tasks in a dynamic environment. Ability to make sound scientific decisions regarding compliance‑related issues with minimal supervision and guidance.
• Work effectively in a team environment and have a high level of personal accountability and responsibility.
• Understanding of MS&T activities including but not limited to: Technology Transfer Strategy and Implementation; Process Development, Product Process Improvement, QbD / PAT; Process Characterization and Control; Process validation
• Comprehensive technical knowledge with a strong science‑and‑risk based mindset
• An understanding of scientific methods, statistical analysis, and standard lab notebook format.
• Robust technical and communication skills

Responsibilities

• Enable reliable supply of vaccines and therapeutics by providing direct scientific and technical leadership to commercial manufacturing operations.
• Anticipate, respond to, and permanently resolve manufacturing issues to safeguard our right to operate and supply.
• Support new processes, equipment, facility design, and other life‑cycle activities to improve quality, efficiency, capacity, and economics.
• Provide fast‑paced campaign support for manufacturing during technical production issues or escalations.
• Represent MS&T as the prime technical contact on contracts and projects.
• Work with manufacturing teams to provide technical support to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes.
• Review technical documents authored by the other team members.
• Develop and maintain structure for process data reviews for internal and external production.
• Develop and draft study plans and protocols as required to support process changes, deviation responses, and regulatory requirements, etc.
• Lead process investigations and drive process improvement initiatives.
• Lead tech transfer of cell culture and purification processes to internal departments.
• Develops and maintains cell lines and cell banks

Skills

Technical leadership

CGMP experience

Statistical analysis

Project management

Communication skills

Education

BS/MS/PhD in Science or Engineering

Tools

JMP

Minitab

Visio

MS Project

Job description

Emergent BioSolutions in Canton, CO is seeking a Senior BioProcess Engineer to provide technical leadership on development, manufacturing, and tech transfer projects. You will plan, coordinate, communicate, and summarize programs, applying CGMP experience to ensure processes are capable, compliant, in control, and cost‑effective.

The role features MSAT leadership across process development, transfer, and continued verification, with responsibilities that include supporting manufacturing