Principal Process Development Engineer, AOC & AAV

Sarepta Inc; Bedford (MA); On-site; USD 136,000 - 170,000; Full time

Job summary

Sarepta Therapeutics, on-site in the United States, seeks a Principal Engineer, Process Development to lead conjugation, purification, and transfer activities for AOC and AAV drug substances. You will guide scale-up, troubleshooting, and regulatory documentation to ensure GMP readiness and robust product quality.

The role requires deep experience in complex biologics, hands-on HPLC, and strong cGMP/CMC knowledge, with collaboration across internal teams and CDMOs/CMOs to advance programs toward

Qualifications

• Ph.D. in chemical engineering, biochemistry, chemistry, pharmaceutical sciences, bioengineering, virology, molecular biology, or related field with 3–5+ years of industry experience; MS with 7–9 years or BS with 10+ years may also be considered.
• Hands-on HPLC experience, including method execution, impurity analysis, troubleshooting, and characterization of biologic or conjugated drug substance products.
• Strong knowledge of drug substance process development, scale-up, GMP manufacturing, and external CDMO/CMO oversight.
• Understanding of product quality attributes (conjugation efficiency, purity, aggregation, residual impurities, vector genome/capsid titer, potency, capsid ratio, endotoxin, bioburden, stability).
• Experience with cGMP expectations, CMC regulatory requirements, process characterization, validation principles, control strategy development, and lifecycle management.

Responsibilities

• Lead process development and optimization for AOC and AAV drug substance manufacturing, including conjugation, purification, UF/DF, concentration, harvest, clarification, capture, polishing, and bulk DS handling.
• Design and execute studies to improve yield, robustness, impurity clearance, and product quality attributes.
• Provide technical oversight of CDMO/CMO process transfer, engineering runs, GMP batch execution, batch record review, deviations, change assessments, and issue resolution.
• Execute hands-on HPLC methods to support process development, impurity profiling, in-process testing, and product quality assessment.
• Develop and maintain drug substance control strategies, including critical process parameters, in-process controls, hold times, raw material controls, and links to critical quality attributes.
• Support scale-up, technology transfer, process comparability, and manufacturing readiness from development through late-stage clinical or commercial production.
• Prepare and review technical protocols, development reports, manufacturing summaries, batch record sections, comparability assessments, and CMC regulatory source documents.
• Troubleshoot development and manufacturing issues related to conjugation, purification, filtration, recovery, AAV productivity, empty/full capsid enrichment, and impurity clearance.
• Partner with internal functions and external partners to align technical plans, manufacturing readiness, and regulatory deliverables.

Skills

Cross-functional leadership

Troubleshooting

Technical writing

cGMP & CMC knowledge

Education

Ph.D. in chemical engineering, biochemistry, chemistry, pharmaceutical sciences, bioengineering, virology, molecular biology, or related field

MS with 7–9 years or BS with 10+ years may be considered

Tools

HPLC

Job description

Sarepta Therapeutics, on-site in the United States, seeks a Principal Engineer, Process Development to lead conjugation, purification, and transfer activities for AOC and AAV drug substances. You will guide scale-up, troubleshooting, and regulatory documentation to ensure GMP readiness and robust product quality.

The role requires deep experience in complex biologics, hands-on HPLC, and strong cGMP/CMC knowledge, with collaboration across internal teams and CDMOs/CMOs to advance programs toward