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
The individual will support analytical testing and related activities conducted within Process Analytics laboratory, Technical Operations to accelerate the process development for AAV derived gene therapy products. The individual will help with product and process characterization using established test methods. Responsibilities include conducting experiments, analyzing and reviewing data, writing technical reports, and supporting analytical method and reference material qualification activities as needed to support the rigorous timelines in delivering our commitment to patients.
The Opportunity to Make a Difference
Conduct sample analysis in accordance with GLP standards using a variety of assay formats including ddPCR, Octet, qPCR, HPLC, CE, AUC, ELISA and Potency methods
Prepare & qualify critical reagents for assay continuity & comparable performance of relevant analytical methods throughout the lifecycle of a program.
Support the development, optimization, qualification and implementation of relevant analytical methods for existing & new programs.
Maintain accurate ELN records for the experiments being conducted.
Author SOP’s, development and qualification reports.
Participate in method qualification activities for the new analytical methods.
Participate in method transfer activities, supporting transfer and comparable establishment of new methods from internal & external labs as necessary.
Responsible for control tracker management for several assays within the Process Analytics function, ensuring that all data is being tracked & within the established criteria.
Assist in training new employees on technical procedures as assigned in standard methods, practices, procedures, and equipment operations.
Maintain inventory of lab reagents & supplies by ensuring timely ordering and plan for any supply backlogs for undisrupted operations within the Process Analytics function.
Support the onboarding and qualification of new equipment and software.
Completing general lab tasks, preventive maintenance and maintaining a clean working area and adhering to proper safety techniques.
More about You
BS/BA in biochemistry, chemistry, biology, or a related discipline with 1-3 years of pharmaceutical industry experience in gene therapy or related disciplines.
We are looking for a candidate who is capable of learning quickly with the goal of executing analytical methods and managing assigned test schedules.
Hands-on experience in bioanalytical techniques such as ddPCR, qPCR, Octet, AUC, ELISA, Capillary Electrophoresis (CE), HPLC and Potency or infectivity assays is also desirable.
Experience in executing analytical assays in BSL-1 and BSL-2 lab.
Excellent organization, documentation and communication skills.
Direct hands-on experience in analytical development or QC of gene therapy products or related pharmaceutical products is highly preferred.
An awareness of ICH, cGMP, cGLP, regulatory guidelines related to pharmaceutical analytical development and quality control.
Ability to troubleshoot and solve technical issues.
Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.
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-Onsite
#LI-ES1
This position requires work on site at one of Sarepta’s facilities in the United States.
The targeted salary range for this position is $68,000 - $85,000 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.
