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.

Key Responsibilities:

· Plan and execute upstream unit operations for the development and optimization of process unit operations. These operations may include 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 · SOP's), 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.

· Documents manufacturing process deviations, conducts impact analyses, risk assessments and root cause analyses and drafts 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

Qualifications & Education Requirements

BS degree or Master’s or Ph.D. degree with equivalent years relevant experience in a biological science or related field.

· Engineer I: BS degree + less than two (< 2) years relevant experience.

· Engineer II: BS degree + two (2) years relevant experience or Master’s with no experience.

· Engineer III: BS degree + five (5) years relevant experience or Master’s with three (3) years experience.

· Senior Engineer: BS degree + eight (8) years relevant experience or Master’s with six (6) years experience.

Preferred Qualifications:

· Experience with viral vector platforms such as AAV, adenovirus, lentivirus, HSV, MVA, baculovirus/Sf9, or other viral vaccine/vector systems.

· Experience supporting GMP manufacturing in a biologics, gene therapy, vaccine, or CDMO environment.

· Familiarity with single-use bioreactors, shake flasks, rocking-motion bioreactors, stirred-tank bioreactors, and single-use assemblies.

· Experience with suspension and/or adherent cell culture systems.

· Experience with HEK293, Sf9, Vero, MDBK, CHO, or other relevant production cell lines.

· Familiarity with upstream unit operations including cell thaw, seed train, expansion, production bioreactor operation, transfection, infection, harvest, and clarification.

· Experience with process characterization, scale-up, scale-down models, engineering runs, PPQ readiness, or continued process verification.

· Knowledge of GMP documentation, deviation investigation, change control, CAPA, and batch record execution.

· Experience using statistical or data analysis tools such as Excel, JMP, Spotfire, Minitab, Python, or similar software.

Physical Requirements

xx medium work (< 50 lbs.) heavy work (< 100 lbs.)

· Physical activity: (check all that apply)

xx repetitive motion xx balancing xx stooping xx lifting

climbing xx kneeling/crouching crawling xx reaching

xx standing xx typing/grasping xx walking xx pushing/pulling xx hearing

· Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.)

· Working conditions (indoor/outdoor, noise levels, hazards, working quarters)

Travel Requirements (0%)

Supervisor Responsibilities

This position does not require previous supervisory experience.