Lab Manager, Quality Control (Friday-Monday Shift)

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 Lab Manager (Shift) will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta’s Gene Therapy pipeline. The QC Lab Manager (Shift) will oversee a team of 2-4 QC Shift operators with responsibilities that include but are not limited to: aseptic cell culture, relative potency testing, infectious titer testing, and execution of replication competent vector assays. The QC Lab Manager (Shift) will work with QC Data Management and QC-Operations teams to guarantee the timely delivery and authorization of test data as well as to ensure that the lab is maintained in a state of inspection readiness, operating on a seven day/week continuous testing schedule. This individual will author/manage deviations, laboratory investigations, data trending, and review of quality documents originating in the QC laboratory. All aspects of this position involve working in a GMP-compliant manner.
This position is onsite 4 days a week (10-hour days) Friday through Monday - Monday with Holiday coverage.

The Opportunity to Make a Difference

• Provide technical leadership and subject matter expertise to the cell culture and bioassay team to ensure the successful execution of all GMP release and stability bioassays executed in support of Sarepta’s Gene Therapy programs (currently 1 commercial program and 5+ active clinical programs).
• Develop and manage a team of 2-4 Quality Control Operators, with a strong emphasis on training and right-first-time performance.
• Schedule testing to ensure the timely delivery of data to support continuous product supply – will be required to maintain a continuous 7 day/week testing schedule, inclusive of holidays.
• Track and trend all cell culture and bioassay test data and reference standard performance data.
• Identify OOS, OOT, invalid, and unexpected test results, institute swift, thorough, and compliant investigations to identify root cause and implement appropriate corrective actions.
• Resolve/close all Quality Events (deviations, CAPAs, investigations, change controls, etc.) promptly and on time. 
• Maintain the laboratory in a compliant GMP-inspection ready state at all times.
• Conduct SME review of laboratory data and authorization of final reports.
• Collaborating with managers/QC Directors to optimize a smooth workflow.
• Collaborating cross functionally to identify and resolve issues.
• Perform other related duties incidental to the work described.

More about You

•  B.S. degree in Biology or Biochemistry with course work emphasizing analytical molecular biology techniques. Additional training in cell 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.
• Two to four years of experience building, developing, and managing GMP Quality Control testing teams is required.
• Experience with Advanced Therapeutic Medicinal Products (ATMPs, gene therapies) is highly desired.
• A strong understanding and practical experience with aseptic