About the role

AI summarised

The Process Development Senior Engineer serves as a Subject Matter Expert in ASM Process Development, providing leadership in cell culture commercial process support. This global role involves leading investigations, managing projects, supporting regulatory activities, and collaborating across functions to drive process optimization and technology transfer. The position requires strong technical expertise in cell culture processes, problem-solving abilities, and experience in regulated environments.

BiotechOnsiteEngineering

Key Responsibilities

Assume a Subject Matter Expert role within ASM Process Development for cell culture commercial process support
Act as Drug Substance Team Leader within the global Product Development Team (PDT); providing stewardship of product lifecycle and process improvement
Lead complicated investigations independently, providing concise communications to teams and leadership
Integrate trends, data and information into plans, deliverables and recommendations
Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives
Lead productivity projects, process optimization, and product life cycle management
Collaborate with cross-functional teams and network drug substance teams to resolve process challenges by applying advanced technical principles and concepts for troubleshooting
Apply best practices to leverage data for more proactive and predictive approaches
Support regulatory filings, audits and inspection, and other CMC activities (e.g author and review regulatory submissions and responses to questions as required)

Requirements

Doctorate degree OR Master’s degree and 2 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience
In depth cell culture process knowledge, including single-use technologies and harvest technologies
Good understanding of process characterization and process scale up to resolve technical issues observed during transfer / manufacturing at large scale
Experienced in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Experienced in Technology Transfer of new process and technology to commercial site
Strong communication skills (technical writing and verbal communication/presentation)
Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
Familiarity with documentation in a highly regulated environment
Ability to independently determine when additional resources are required to solve problems
Ability to provide solutions to a large variety of technical problems
Able to lead small team and lead projects