Principal Engineer, Process Development

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

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

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: Importance of the Role

The Principal Engineer will support development scale-up technology transfer and external manufacturing oversight for Sareptas 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 Sareptas 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

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 35 years of relevant industry experience; MS with 79 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

Were always looking for solution-oriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.

#LI-Onsite

This position requires work on site at one of Sareptas facilities in the United States.

The targeted salary range for this position is $136000 - $170000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas 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.