Principal Engineer, Process Development

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

Job summary

Sarepta Therapeutics, on-site in the United States, seeks a Principal Engineer, Process Development to lead conjugation, purification, and transfer activities for AOC and AAV drug substances. You will guide scale-up, troubleshooting, and regulatory documentation to ensure GMP readiness and robust product quality.

The role requires deep experience in complex biologics, hands-on HPLC, and strong cGMP/CMC knowledge, with collaboration across internal teams and CDMOs/CMOs to advance programs toward

Qualifications

• Ph.D. in chemical engineering, biochemistry, chemistry, pharmaceutical sciences, bioengineering, virology, molecular biology, or related field with 3–5+ years of industry experience; MS with 7–9 years or BS with 10+ years may also be considered.
• Hands-on HPLC experience, including method execution, impurity analysis, troubleshooting, and characterization of biologic or conjugated drug substance products.
• Strong knowledge of drug substance process development, scale-up, GMP manufacturing, and external CDMO/CMO oversight.
• Understanding of product quality attributes (conjugation efficiency, purity, aggregation, residual impurities, vector genome/capsid titer, potency, capsid ratio, endotoxin, bioburden, stability).
• Experience with cGMP expectations, CMC regulatory requirements, process characterization, validation principles, control strategy development, and lifecycle management.

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.

Skills

Cross-functional leadership

Troubleshooting

Technical writing

cGMP & CMC knowledge

Education

Ph.D. in chemical engineering, biochemistry, chemistry, pharmaceutical sciences, bioengineering, virology, molecular biology, or related field

MS with 7–9 years or BS with 10+ years may be considered

Tools

HPLC

Job description

Why Sarepta? Why Now?

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

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 Opportunity to Make a Difference

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.

More About You

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

Primary Responsibilities include:

• 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.

Education And Skills 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.

What Now?

We're always looking for solution-oriented, critical thinkers.

This position requires work on site at one of Sarepta's facilities in the United States.

The targeted salary range for this position is $136,000 - $170,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.