What are the responsibilities and job description for the QC Associate II, Chemistry position at Sarepta Therapeutics?
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:
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 QC Associate II, Chemistry will work as a member of the Quality Control-Internal Testing team and will be responsible for testing gene therapy products using compendial (USP/EP/JP) and non-compendial test methods. All testing will be done in compliance with current Good Manufacturing Processes (cGMP) and will support clinical and commercial lot release and stability activities. Available positions are all facility-dependent and require a full-time on-site presence (hybrid or remote hours are not available). All positions will be based in the Sarepta Quality Control Laboratories located in Andover, MA. The successful candidate will have hands-on experience with compendial testing: pH, Osmolality, Appearance, Volume for injection, and sub-visible particle enumeration. Additionally, the successful candidate should have training and understanding of basic separation sciences i.e. Liquid Chromatography (HPLC/UPLC) and Analytical Ultra Centrifugation (AUC). Experience with Dynamic Light Scattering and Mass Spectroscopy is a plus. The required work involves handling and testing viral samples in a BSL-2 environment. Additionally, the successful candidate will assist in authoring and managing quality events (deviations, CAPAs, change controls etc.), as well as conducting data analysis and data trending.The Opportunity to Make a Difference
Sample preparation and test method execution.
Troubleshooting and optimization of test methods as needed.
Supporting qualification/verification/validation and analytical technical transfer activities.
Participate (as required) in the preparation and qualification of in-house reference materials.
Creating and maintaining clear and concise laboratory records in compliance with current Good Documentation Practices (cGDP).
Maintaining laboratory equipment in a functional, qualified, inspection-ready state at all times.
Collaborating with team leads and managers to optimize a smooth workflow. Escalates issues as they are discovered.
Collaborating cross functionally to resolve issues.
More about You
B.S. degree in Chemistry or Biochemistry with course work emphasizing analytical chemistry. Additional training in cell biology or molecular biology is a plus.
Two to five (2-5) years of relevant experience in a regulated GMP environment is necessary. Experience working with gene therapy products is highly desired.
A strong understanding of Quality Control testing and current GMPs is desired.
Experience with basic analytical chemistry techniques is necessary. Chromatography, AUC or DLS experience is a plus.
Experience with general laboratory organization, experimental execution and documentation (GDP), and adherence to cGMP is necessary.
Must be able to operate as a part of a team.
Attention to details is a must.
Effective written and verbal communication skills.
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.
Salary : $76,000 - $95,000
