What are the responsibilities and job description for the Lead QC Associate, 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 Lead QC Associate, Chemistry will work as a member of the Quality Control-Internal testing team and will be responsible for oversight and testing of gene therapy products using compendial (USP/EP/JP) and non-compendial test methods. The lead role is a combination manager-individual contributor role. The lead will oversee one to three junior QC analysts while also performing routine lab work. The split of managerial and independent contributor responsibilities will be assessed against the number of direct reports assigned. 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 appropriate training with relevant practical experience in the separation sciences, with specific experience executing Liquid Chromatography (HPLC/UPLC), LC-Mass Spec, and and Analytical Ultra Centrifugation (AUC) test methods. Additionally, hands-on experience with compendial testing: pH, Osmolality, Appearance, Volume for injection, and sub-visible particle enumeration is required. Experience with Dynamic Light Scattering is a plus. The required work involves handling and testing viral samples in a BSL-2 environment.The Opportunity to Make a Difference
Oversight of one to three junior QC analysts. Oversight includes training, scheduling, and data review.
Sample preparation and test method execution.
Troubleshooting and optimization of test methods as needed.
Supporting method development, qualification/verification/validation and analytical technical transfer activities.
Preparation and qualification of in-house reference materials.
Creating and maintaining clear and concise laboratory records in compliance with current Good Documentation Practices (cGDP).
Participating in GMP regulatory audits and inspections.
Maintaining laboratory equipment in a functional, qualified, inspection-ready state at all times.
Collaborating with managers/QC Directors to optimize a smooth workflow.
Collaborating cross functionally to identify and 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.
A minimum of five 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 Liquid Chromatography, LC-MS is necessary. AUC and/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 are 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.
Salary : $112,000 - $140,000
