Principal Engineer, Process Development
Sarepta Therapeutics
August 22, 2026
On-site
Bedford, MA
Operations
The Principal Engineer, Process Development 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, providing technical leadership for internal process development and CDMO/CMO manufacturing with responsibility for process robustness, product quality, GMP readiness, technical documentation, and CMC regulatory support.
Primary Responsibilities:
- Lead process development and optimization for AOC and AAV drug substance manufacturing (conjugation, purification, UF/DF, concentration, harvest, clarification, capture, polishing, bulk DS handling).
- Design and execute studies to improve yield, robustness, impurity clearance, and product quality attributes.
- Oversee CDMO/CMO process transfer, engineering runs, GMP batch execution, batch record review, deviations, change assessments, and issue resolution.
- Execute hands-on HPLC methods for impurity profiling, in-process testing, and product quality assessment.
- Develop and maintain drug substance control strategies (CPPs, in-process controls, hold times, raw material controls) linked to CQAs.
- Support scale-up, technology transfer, process comparability, and manufacturing readiness through late-stage clinical or commercial production.
- Prepare/review protocols, development reports, manufacturing summaries, batch record sections, comparability assessments, and CMC regulatory source documents.
- Troubleshoot issues related to conjugation, purification/filtration/recovery, AAV productivity, empty/full capsid enrichment, and impurity clearance.
- Partner with internal and external stakeholders on technical plans, readiness, and regulatory deliverables.
Education & Skills Requirements:
- Ph.D. with 3–5+ years relevant industry experience; MS (7–9 years) or BS (10+ years) may also be considered.
- Strong background in AOC/bioconjugates/oligonucleotide therapeutics/Fab intermediates/AAV/viral vector manufacturing or other complex biologics (strongly preferred).
- Hands-on HPLC experience (method execution, impurity analysis, troubleshooting, characterization).
- Knowledge of drug substance process development, scale-up, technology transfer, GMP manufacturing, and external CDMO/CMO oversight.
- Understanding of relevant CQAs (e.g., conjugation efficiency, purity, aggregation, residual impurities, vector genome/capsid titer, potency, empty/full capsid ratio, endotoxin, bioburden, stability-indicating attributes).
- Ability to interpret process/analytical data for development and regulatory documentation.
- Working knowledge of cGMP, CMC regulatory requirements, process characterization/validation principles, control strategy development, lifecycle management.
- Strong technical writing, communication, troubleshooting, and cross-functional leadership.
- CDMO/CMO and external technical team experience preferred.
Application/Work Requirements:
- On-site work at a Sarepta facility in the United States.
- Candidates must be authorized to work in the U.S.
Primary Responsibilities:
- Lead process development and optimization for AOC and AAV drug substance manufacturing (conjugation, purification, UF/DF, concentration, harvest, clarification, capture, polishing, bulk DS handling).
- Design and execute studies to improve yield, robustness, impurity clearance, and product quality attributes.
- Oversee CDMO/CMO process transfer, engineering runs, GMP batch execution, batch record review, deviations, change assessments, and issue resolution.
- Execute hands-on HPLC methods for impurity profiling, in-process testing, and product quality assessment.
- Develop and maintain drug substance control strategies (CPPs, in-process controls, hold times, raw material controls) linked to CQAs.
- Support scale-up, technology transfer, process comparability, and manufacturing readiness through late-stage clinical or commercial production.
- Prepare/review protocols, development reports, manufacturing summaries, batch record sections, comparability assessments, and CMC regulatory source documents.
- Troubleshoot issues related to conjugation, purification/filtration/recovery, AAV productivity, empty/full capsid enrichment, and impurity clearance.
- Partner with internal and external stakeholders on technical plans, readiness, and regulatory deliverables.
Education & Skills Requirements:
- Ph.D. with 3–5+ years relevant industry experience; MS (7–9 years) or BS (10+ years) may also be considered.
- Strong background in AOC/bioconjugates/oligonucleotide therapeutics/Fab intermediates/AAV/viral vector manufacturing or other complex biologics (strongly preferred).
- Hands-on HPLC experience (method execution, impurity analysis, troubleshooting, characterization).
- Knowledge of drug substance process development, scale-up, technology transfer, GMP manufacturing, and external CDMO/CMO oversight.
- Understanding of relevant CQAs (e.g., conjugation efficiency, purity, aggregation, residual impurities, vector genome/capsid titer, potency, empty/full capsid ratio, endotoxin, bioburden, stability-indicating attributes).
- Ability to interpret process/analytical data for development and regulatory documentation.
- Working knowledge of cGMP, CMC regulatory requirements, process characterization/validation principles, control strategy development, lifecycle management.
- Strong technical writing, communication, troubleshooting, and cross-functional leadership.
- CDMO/CMO and external technical team experience preferred.
Application/Work Requirements:
- On-site work at a Sarepta facility in the United States.
- Candidates must be authorized to work in the U.S.