Principal Engineer, Process Development

Role: Principal Engineer supporting development, scale-up, and external manufacturing oversight of Sarepta's antibody-oligonucleotide conjugate (AOC) and adeno-associated virus (AAV) biologics. Responsibilities: lead process development and optimization, design studies to enhance yield and robustness, oversee process transfer and GMP batch execution with CDMO/CMO partners, conduct hands-on analytical testing (HPLC), develop control strategies, and support regulatory documentation. Qualifications: Ph.D. in chemical engineering, biochemistry, chemistry, or related field with 3-5+ years of industry experience (or equivalent), with strong expertise in complex biologics including bioconjugates, AAV vectors, or viral manufacturing. Skills include hands-on HPLC proficiency, deep understanding of process development, scale-up, GMP, and external oversight, along with data interpretation and technical documentation. Preferred: experience working with CDMOs/CMOs and knowledge of product quality attributes such as purity, aggregation, vector titers, and stability. High-value details: focus on biologics manufacturing for gene therapy and conjugates, supporting late-stage clinical or commercial production. Work setup: on-site in the U.S.; no travel specified.