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.
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