Principal Engineer, Process Development

Why Sarepta?

Sarepta is at the forefront of genetic medicine, holding a leadership position in Duchenne muscular dystrophy (Duchenne) and building a robust portfolio across muscle, central nervous system, and cardiac diseases. In 2023, Sarepta launched its fourth therapy and the first-ever gene therapy to treat Duchenne. We seek individuals who see unlimited potential in themselves and are motivated by an unwavering commitment to patients.

What Sarepta Offers

Sarepta supports its community by acknowledging that people bring their whole selves to work. We offer a range of benefits and work-life resources to support physical and emotional wellness, financial wellness, and caregivers. For a full list of comprehensive benefits, visit our website: https://www.sarepta.com/join-us.

About the Role

The Principal Engineer will support development, scale-up, technology transfer, and external manufacturing oversight for Sarepta’s antibody-oligonucleotide conjugate (AOC) and adeno-associated virus (AAV) drug substance programs. This role provides technical leadership across internal process development and CDMO/CMO manufacturing activities, focusing on process robustness, product quality, GMP readiness, technical documentation, and CMC regulatory support.

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.

Requirements

• Ph.D. in chemical engineering, biochemistry, chemistry, pharmaceutical sciences, bioengineering, virology, molecular biology, or related field with 3–5+ years of relevant industry experience; MS with 7–9 years or BS with 10+ years may also be considered.
• Technical background in AOC, antibody-drug conjugates, bioconjugates, oligonucleotide therapeutics, Fab/antibody intermediates, AAV vectors, viral vector manufacturing, or other complex biologics is strongly preferred.
• Hands-on HPLC experience, including method execution, impurity analysis, method troubleshooting, and characterization of biologic or conjugated drug substance products.
• Strong knowledge of drug substance process development, scale-up, technology transfer, GMP manufacturing, and external CDMO/CMO oversight.
• Understanding of relevant product quality attributes, including conjugation efficiency, purity, aggregation, residual impurities, vector genome/capsid titer, potency, empty/full capsid ratio, endotoxin, bioburden, and stability-indicating attributes.
• Ability to interpret process, analytical, characterization, and stability data to support development decisions, investigations, comparability assessments, and regulatory documentation.
• Working knowledge of cGMP expectations, CMC regulatory requirements, process characterization, validation principles, control strategy development, and lifecycle management.
• Strong technical writing, communication, troubleshooting, and cross-functional leadership skills.
• Experience working with CDMOs/CMOs, external technical teams, or cross-functional development workstreams is preferred.
• Demonstrated alignment with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation, and Compassion.

Pay

The targeted salary range for this position is $136,000 - $170,000 per year. The salary offer considers factors including education, training, experience, external market conditions, criticality of role, and internal equity.

Benefits

Sarepta Therapeutics offers a competitive compensation and benefit package. Candidates must be authorized to work in the U.S.