MSAT Engineer, Upstream

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

Do you have experience in Root cause analysis?, Do you have a Bachelor's degree?, 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., * Do you have at least 5 years of experience in a GMP-regulated biologics, cell therapy, gene therapy, or pharmaceutical environment?

• Do you have experience reviewing or approving GMP quality documentation such as batch records, deviations, CAPAs, change controls, specifications, or product release documentation?
• Do you have experience hosting or supporting FDA, client, or regulatory inspections?
• Do you have experience working in a gene therapy, cell therapy, biologics, vaccine, or CDMO environment?

Education:

• Bachelor's (Preferred)

Experience:

• GMP biologics, cell therapy, or gene therapy quality: 5 years (Required)

Pulled from the full job description

• Parental leave
• 401(k)
• Health insurance
• Retirement plan
• 401(k) matching
• Paid time off
• Vision insurance, * 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Retirement plan
• Vision insurance