Onsite Principal Engineer, Biologics Process Development

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

Benefits offered by this job

On-site work

Competitive compensation and benefits

Equal Opportunity Employer

Job summary

Sarepta Therapeutics is seeking a Principal Engineer, Process Development on site in the United States. You will lead development and scale-up for AOC and AAV drug substances, overseeing technology transfer and external manufacturing to ensure GMP readiness and product quality.

The role requires deep expertise in complex biologics, analytical methods (HPLC), and cross-functional leadership to drive programs from development through late-stage production.

Qualifications

• PhD in chemical engineering, biochemistry, chemistry, pharmaceutical sciences, bioengineering, virology, molecular biology, or related field with 3–5+ years of industry experience.
• Hands-on HPLC experience including method execution and impurity analysis.
• Strong knowledge of drug substance process development, GMP manufacturing, and external CDMO/CMO oversight.

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.
• Develop and maintain drug substance control strategies, including critical process parameters, in-process controls, hold times, raw material controls, and links to CQAs.
• Support scale-up, technology transfer, process comparability, and manufacturing readiness from development through late-stage clinical or commercial production.

Skills

HPLC execution

cGMP knowledge

Technical writing

Cross-functional leadership

CDMO/CMO collaboration

Education

Ph.D. in chemical engineering/biochemistry/chemistry/pharmaceutical sciences/bioengineering/virology/molecular biology

MS in related field (7–9 years)

BS in related field (10+ years)

Tools

HPLC

Job description

Sarepta Therapeutics is seeking a Principal Engineer, Process Development on site in the United States. You will lead development and scale-up for AOC and AAV drug substances, overseeing technology transfer and external manufacturing to ensure GMP readiness and product quality.

The role requires deep expertise in complex biologics, analytical methods (HPLC), and cross-functional leadership to drive programs from development through late-stage production.