Gene Therapy Quality Control Associate II - Cell-Based Assays
Gene Therapy Quality Control Associate II - Cell-Based Assays
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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
This individual will work with a team engaged in providing technical services on cellbased assays (Potency assay Infectious titer TCID50 assay). The individual will support the optimization of cell and molecular biology assays being conducted in Andover MA and conduct laboratory support processes such as maintaining cell cultures. The candidate must have handson experience in cell culture techniques in vitro Potency Western blot (automated preferred) protein extraction and protein quantification methods. Experience with qPCR and/or ddPCR are also desired skills. The work involves performing assays in a QCGMP BSL2 environment and the individual will work alongside other team members to assess and improve assay performance and participate in qualification and validation activities. All aspects of this position involve working in a GMPcompliant manner.The individual will also assist in data trending and analysis maintaining laboratory equipment and management of materials and reagents. This position is onsite 5 days a week and requires occasional coverage late in the evening and on weekends.
The Opportunity to Make a Difference
- Optimize cell culture conditions to support of cellbased assays
- Support troubleshooting and optimization of cell and molecular assays including assay development & validations in accordance with cGMP regulations
- Author quality documents including SOPs and test methods
- Prepare qualify and release standards for the in vitro potency methods
- Test new cell lines for use in new potency assays
- Maintaining cell banks on cryogenic storage
- Improve robustness and throughput for existing cell assays integrating automation platforms
- Support the method development transfer and qualification/validation activities associated with the cellbased potency assays for AAVbased gene therapy products including protein and mRNAbased expression assays
- Create and maintain clear concise lab records and documentation
- Sample management: Inventory and tracking of incoming and outgoing samples
- Collaborate with team leads and managers to optimize a smooth workflow for collaboration on team activities
- Perform other related duties incidental to the work described
More about You
- B.S. degree in molecular biology cell biology or virology with 23 years relevant experience.
- Understanding of operating and method development using Jess/ Capillary electrophoresis western blotting.
- Working experience in a cGMP environment is required.
- An understanding of molecular techniques including potencybased immunoassays ELISA immunoblotting qPCR ddPCR and cell banking is necessary.
- Hands on experience running proteinbased immunoassays and/or qPCR/ddPCR assays.
- Familiarity with primary mammalian cell culture in particular myoblasts.
- Transductions with AAV vectors and conditions to optimize payload delivery and expression
- Experience in developing validating optimization and deploying cell and molecular biology test methods is highly desired.
- Experience in general laboratory organization experimental design and documentation (GDP) with adherence to cGMP is necessary.
- Operate as a part of a team with experience in coordinating and collaborating with peers.
- 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
