New

Lab Manager, Quality Control (Friday-Monday Shift)

Sarepta Therapeutics
United States, Massachusetts, Andover
Feb 24, 2025
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 cell culture (mammalian, insect, and bacterial cell lines) is required. A strong understanding and practical experience with relative potency assays, infectious titer assays, and replication competent vector assays are required. Experience with various molecular biology assays (immuno-assays, ELISA, SDS-PAGE, CE-SDS, etc.), classical cell-based virology assays (TCID50, plaque assays, titer reduction assays, neutralization assays etc.) as well as analytical chemistry methodologies and principles is required. Experience with general laboratory organization, experimental execution and documentation (GDP), and adherence to cGMP is necessary. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems - Veeva, Theia, LIMS, IDBS. Operate as a part of a team with experience supervising and training individuals in a functional, safe working environment while maximizing laboratory efficiency. 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. #LI-Onsite #LI-TR1 This position requires work on site at one of Sarepta's facilities in the United States. The targeted salary range for this position is $112,000 - $140,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.