About the role

AI summarised

The Process Development Senior Engineer is responsible for leading process development initiatives, optimizing manufacturing processes, and supporting technology transfers in semiconductor or advanced manufacturing environments. This role involves collaboration with cross-functional teams to improve yield, reliability, and performance through data-driven experimentation and process characterization.

BiotechOnsiteProcess Development

Key Responsibilities

Assume a Subject Matter Expert role within ASM Process Development for cell culture and/or purification commercial process support.
Act as Drug Substance Team Leader within the global Product Development Team (PDT); providing stewardship of product lifecycle and process improvement.
This is a global role that interacts with other experts in the areas of Drug Product, Regulatory Affairs, Quality, Business Operations, Supply Chain, and Attributes Sciences.
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.

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 6+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries At least 4 years’ experience with regulated environments (i.e.
cGMP) required In depth cell culture and/or purification 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.
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 Thrive What you can expect of us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.