Lead Process Development Engineer – Bioconjugates & AAV

Biopharma Careers; Town of Bedford (NY); On-site; USD 136,000 - 170,000; Full time

Job summary

Sarepta Therapeutics is seeking a Principal Engineer, Process Development, to lead development, scale‑up, and technology transfer for AOC and AAV drug substances. You will oversee GMP readiness, documentation, and external manufacturing partnerships to ensure product quality and regulatory readiness.

The ideal candidate has deep experience with complex biologics or bioconjugates, strong analytical skills (HPLC), and a track record of cross‑functional leadership to advance programs from

Qualifications

• PhD in chemical engineering or related field with 3–5+ years of industry experience.
• Hands-on HPLC experience with assay development and impurity profiling.
• Strong knowledge of GMP manufacturing and CMC regulatory expectations.

Responsibilities

• Lead process development and optimization for AOC and AAV drug substances.
• Drive scale-up, technology transfer, and GMP readiness for manufacturing.
• Provide technical oversight of CDMO/CMO process transfer and batch execution.
• Prepare and review development reports, protocols, and regulatory documents.
• Troubleshoot conjugation, purification, and impurity clearance issues.

Skills

Process development

Scale-up

Technology transfer

GMP readiness

HPLC

CDMO/CMO oversight

Cross-functional leadership

Education

PhD in chemical engineering

Biochemistry/chemistry background

Tools

AOC

AAV vectors

Job description

Sarepta Therapeutics is seeking a Principal Engineer, Process Development, to lead development, scale‑up, and technology transfer for AOC and AAV drug substances. You will oversee GMP readiness, documentation, and external manufacturing partnerships to ensure product quality and regulatory readiness.

The ideal candidate has deep experience with complex biologics or bioconjugates, strong analytical skills (HPLC), and a track record of cross‑functional leadership to advance programs from