MSAT Engineer, Upstream

Job Overview

Ascend Advanced Therapies is seeking a Upstream MSAT Engineer to support technology transfer, process implementation, scale‑up, manufacturing support, and process lifecycle activities for viral vector programs within a CDMO environment. This role will focus on upstream processing for viral vector manufacturing, including cell culture expansion, transfection and/or infection‑based production systems, bioreactor operations, process troubleshooting, process characterization, and GMP manufacturing support.

The successful candidate will work cross‑functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Analytical Development, Supply Chain, and Project Management to ensure robust technical transfer and execution of client programs from early clinical through late‑stage and commercial readiness.

• Plan and execute upstream unit operations for the development and optimization of process unit operations, including seed cultures and cell culture expansion in both adherent and suspension platforms, and scale‑up (bioreactors).
• Perform upstream unit operations in support of GMP manufacturing campaigns.
• Support execution of upstream unit operations as needed.
• Collect, record, analyze and summarize data in the course of biologics production and processing.
• Trend in‑process manufacturing data to monitor process control and support campaign summary reports.
• Familiarity with modern protein, viral or vaccine production/purification methods.
• Support process development and in‑house manufacturing activities for generation of viral vectors for non‑GLP and GLP study protocols.
• Assist in maintaining laboratory/manufacturing supplies and equipment.
• Author and revise relevant documentation such as standard operation procedures (SOPs), work instructions (WIS), specifications (SPC), protocols (PRO), reports (RPT), forms (FRM) including production/batch records in support of bioprocessing unit operations associated with biomanufacturing campaigns and process development activities.
• Maintain documents in accordance with GDP and other relevant quality standards.
• Document manufacturing process deviations, conduct impact analyses, risk assessments and root‑cause analyses and draft corrective and preventive action plans.
• Advanced proficiency in basic biological techniques, methods and guidelines relevant to a biological lab.
• Working knowledge of manufacturing industry standards in quality cGMP.
• Other duties as assigned.

• BS degree, Master’s degree, or Ph.D. degree with equivalent years of relevant experience in a biological science or related field.
• Engineer I: BS degree + less than two (