QC Associate II Potency
QC Associate II Potency
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$ 76000 - 95000
1 Vacancy
Job Description
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 limbgirdle 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.
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 worklife 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 QC Associate II Potency will work as a member of the Quality ControlInternal Testing team and will be responsible for testing gene therapy products using cellbased and ELISA based 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 facilitydependent and require a fulltime onsite 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 handson experience with either cellbased invitro potency assays infectious virus titer assays SDSPAGE Automated Western blot assays and enzymelinked immunosorbent assays (ELISA). The required work involves handling and testing viral samples in a BSL2 environment. The successful candidate will also 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 .
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 inhouse reference materials.
Creating and maintaining clear and concise laboratory records in compliance with current Good Documentation Practices (cGDP).
Maintaining laboratory equipment in a functional and inspectionready state.
Collaborating with team leads and managers to optimize a smooth workflow. Escalating issues as they are discovered.
Collaborating cross functionally to resolve issues.
More about You
B.S. degree in biology or biochemistry with course work emphasizing molecular biology or cell biology.
Two to five 25 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 cellbased testing and ELISA based testing is necessary.
Experience with general laboratory organization experimental 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
Were always looking for solutionoriented 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.
Required Experience:
IC
Employment Type
Full-Time
