Principal Engineer, Process Development

Sarepta Therapeutics•Bedford, MA

13h•$136,000 - $170,000•Onsite

About The Position

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 will provide technical leadership across internal process development and CDMO/CMO manufacturing activities, with responsibility for process robustness, product quality, GMP readiness, technical documentation, and CMC regulatory support. The Principal Engineer, Process Development role is responsible for providing technical leadership across Sarepta’s AOC and AAV drug substance programs, with a focus on process development, scale-up, technology transfer, external manufacturing oversight, and GMP readiness. The position will support internal and CDMO/CMO activities by driving process robustness, product quality, control strategy development, troubleshooting, technical documentation, and CMC regulatory deliverables. The ideal candidate will bring deep experience in complex biologics or bioconjugate manufacturing, hands-on analytical capability such as HPLC, strong knowledge of cGMP and CMC expectations, and the communication and cross-functional leadership skills needed to advance programs from development through late-stage clinical or commercial production.

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.
Recognized by peers, colleagues, managers, and direct reports for attributes aligned with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation, and Compassion.

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.