Single Use Process Scientist
Job Title & Summary
The
Single Use Process Scientist
supports the design, implementation, and operation of single-use technologies for GMP biologics and ADC manufacturing.
The role provides technical expertise in process development, equipment setup, troubleshooting, and manufacturing support for new product introductions and technical transfers.
Responsibilities
Conduct gap analysis, facility fit studies, process safety and risk assessments for NPI activities involving single-use technologies.
Support development and optimization of single-use process steps including upstream operations, mixing, UF/DF, and chromatography.
Prepare and update specifications, protocols, procedures, batch records, and other NPI-related documentation.
Set up, operate, and troubleshoot single-use equipment and assemblies; provide operational floor support.
Lead or assist PFMEA, EHS risk assessments, investigations, and change control activities.
Support and train manufacturing personnel in the use of single-use systems and technologies.
Collaborate with MS&T, global science, and quality teams on process development, technical transfer, and NPI activities.
Ensure compliance with GMP, EHS policies, regulatory requirements, and site procedures.
Support cross-functional initiatives, cost-improvement projects, and daily operational decision-making.
Work autonomously and escalate significant decisions to the NPI Technical Manager as needed.
Apply strong knowledge of single-use technologies, including design of new single-use assemblies for projects.
Provide technical support in ADC manufacturing environments.
Support process transfer activities in GMP facilities.
Lead design and execution of cleaning studies.
Provide expertise across upstream processing, UF/DF, mixing, single-use systems, and chromatography.
Communicate effectively and influence decision-making in cross-functional teams.
Requirements
Third-level degree in a relevant engineering, science, or technical discipline (required).
Master's degree in a relevant discipline (desirable).
Minimum 3 years' experience in GMP pharmaceutical or biologics environments with exposure to process engineering, manufacturing, or technical transfer (desirable).
Experience with single-use systems including bioreactors, mixers, tubing, connectors, and assembly design.
Experience working in ADC manufacturing facilities.
Hands-on experience with equipment setup, operation, and troubleshooting.
Experience with cleaning study design and biologics unit operations (upstream, UF/DF, mixing, chromatography).
Strong GMP documentation, quality compliance, and batch record experience.
Strong communication, teamwork, and training capabilities with the ability to influence decisions.
High attention to detail, strong problem-solving ability, and commitment to EHS and regulatory compliance.
Ability to prioritize workload, meet deadlines, and work independently with accountability.