Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re 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:
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
With exciting advancement of multiple gene therapy programs from early clinical to pivotal and commercial stages, we are actively recruiting for a Lead Engineer of MSAT to support Sarepta’s diverse gene therapy portfolio and to deliver new treatments for patients. The ideal candidate should be well-versed in all CMC aspects related to early clinical, late stage and commercial programs.
The incumbent is accountable for providing key input to MSAT, Manufacturing and Quality Leaders in support of late-stage technology transfer, manufacturing and process validation at multiple CMOs; and is responsible for ensuring Sarepta methods, processes and control strategies meet phase-appropriate GMP requirements and agency expectations. This person will assure compliance following quality-by-design principles and through execution of effective qualification/validation policy and procedures. This person will also lead MSAT lab work to support process robustness and improvements for post-PPQ/commercial programs, and drive opportunities for increased business and operational efficiencies.
The Opportunity to Make a Difference
- Be responsible for authoring GMP process descriptions, collaborating with cross-functional project teams, reviewing and ensuring alignment with CMO batch records and other GMP documentations.
- Collaborate with PD colleagues in FMEA assessment, lead process control strategy development and alignment between CMOs.
- Review and approve other internal source documents, such as Pilot process description, PD/Pilot study reports and various risk assessments to ensure process knowledge transfer to MSAT
- Provide technical guidance to support late-stage viral vector manufacturing and PPQ campaigns through technical capability development and deployment
- Support regulatory filings by drafting INDa, briefing book and BLA sections and authoring responses to regulatory questions
- Collaborate with the Data Management team to support program specific setup and to ensure incorporation of GMP learnings for process/product optimization and improvement
- Advance MSAT business processes including authoring policy documents and SOPs
- Lead MSAT related lab work in supporting investigation, change control and continuous improvement projects
More about You
- Degree in Engineering or Life/Pharmaceutical Sciences.
- B.S. with 8+ years, M.S. with 5+ years, or Ph.D. with 1-3 years of Process Development and/or MSAT experience.
- Experience/skills in technology transfers, risk assessment and GMP requirements are required.
- Knowledge of regulatory and compliance requirements for GMP production, drug substance development and process validation is required.
- Understanding of statistical software tools for design and analysis of experiments is required, experience using statistical software for process performance/CPV analysis is a plus.
- Experience in gene therapy process development, characterization and/or manufacturing is highly desirable.
- Experience developing and managing technical relationships with external CMOs is a plus.
- Strong collaborative, communication and influencing skills and ability to work well in a cross-functional, matrixed environment and to gain buy-in internally and externally.
- The ability to multi-task, prioritize and work well as part of a team is essential.
- Proactive and efficient in performing tasks, flexible and able to adapt to company growth and evolving responsibilities.
- Some travel to CMO site may be required.
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re 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-Hybrid
#LI-ES1
This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $112,000 - $140,000 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.
