MSAT Scientist

About the Role

We have a great opportunity for an MSAT Downstream Scientist to join our team, located in Wilson, NC. Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new Bio-Processing Facility in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes. In this critical role within the MSAT team, the downstream scientist will support reduced scale downstream model studies in the lab. This position will also support commercial product introduction through technology transfer, assist process validation, and provide technical support for manufacturing investigations and health authority inspections.

Key Responsibilities

• Support MSAT laboratory start up activities including the preparation of SOPs and working instructions, as well as coordinating laboratory instrument installation, commissioning and qualification.
• Conduct reduced scale chromatography and filtration studies in the MSAT lab including writing protocols/reports, preparing buffer/reagents, and conducting data analysis.
• Maintain lab readiness including sample management, equipment calibration/verification, and maintenance.
• Collaborate with the manufacturing operations department to collect samples from the production floor and process the samples in the MSAT lab.
• Support training within the group on new processes, procedures, and use of equipment in the lab.
• Foster a culture of lean principles and continuous improvement within the department while promoting collaboration with internal and external partners.

Requirements & Tech Stack

• Proven experiences in chromatography purification, viral filtration, Ultrafiltration/Diafiltration for monoclonal antibody purification processes.
• Strong hands-on laboratory mindset and experiences with laboratory scale chromatography purification systems (AKTA/UNICORN), with the ability to develop the Unicorn methods/recipe, pack columns and execute experiments.
• Excellent oral and written communication skills. Strong technical writing capability with keen attention to detail.
• Self-motivated with a dedication to staying up to date with regulatory and technical developments in the industry.
• Strong collaboration skills in a multi-functional team environment.
• Consistent track record to adapt to rapid changes in project priorities and requirements.

Qualifications

• A minimum Bachelors Degree in Biology, Pharmacy, Chemical Engineering, Bioprocess Engineering, or similar field required.
• B.S. with a minimum 2 years of relevant experience or M.S. with 0-2 years relevant experience.

Preferred

• Prior experience working in a regulated biologics or pharmaceutical manufacturing environment.
• Experience in lab digital projects (e.g. lab electronic notebook implementation, integration of lab equipment into data systems).

Other

• Full-time on-site support.
• Availability of occasionally working non-standard hours.