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:
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
Located in Andover, Massachusetts, Sarepta Therapeutics is searching for a Sr. Manager Laboratory Systems to ensure the implementation of new solutions and the improvement of existing systems for the Sarepta Therapeutics Laboratory Systems. Reporting to the Associate Director of Laboratory Systems, this role will interact with Scientific Business units such as Research, Quality, TechOps, and Small-Scale Manufacturing to primarily assess laboratory system technology needs/requirements and workflows/processes. In addition will provide technical support in setup/configuration, administration, and support for systems (ELN, LIMS, etc.). As Sr. Manager Laboratory Systems, facilitate the implementation of systems and assist with the creation of validation documentation, including GxP Assessments, Change Control, Validation Plans, Risk, Assessments, Requirements/Design Specifications, IQ/OQ/PQ Protocols, Matrices, and other documentation.
The Opportunity to Make a Difference
- Act as an expert for Enterprise Laboratory System (ELS)solutions.
- Collaborate closely with business stakeholders and document requirements and workflows for the ELS as the platforms mature and support the development effort provided by system analysts and system engineers. Responsibilities may include taking the lead as a lab proxy to ensure new functionality meets requirements, writing acceptance test scripts for functionality, and participating in the validation of software releases.
- This position will aid with in-depth analysis and interpretation of industry regulatory standards and standard practices related to laboratory analytical systems implementations.
- Support delivering projects and initiatives in a timely and qualitative manner.
- Participate in the demand management process to assist the business in establishing business cases relating to new systems or potential system changes.
- Highlight potential risks and act proactively to resolve issues.
- Participate and provide support for large cross-functional projects as needed.
- The candidate will be expected to be aware of advances in the various scientific and scientific computing fields, either by additional formal training or attending scientific gatherings or workshops, as required.
- Provide application support for LIMS and other laboratory software as a level 2/3 SME, including version control, upgrades, patching and deployments, and system maintenance.
- Propose, lead, and deploy continuous improvement projects within the ELS.
- Participate and provide support for large cross-functional projects as needed.
More about You
- A bachelor’s degree in science, technology, or another relevant academic discipline is required.
- Experience with (LIMS) Laboratory Information Management Systems, (ELN) Electronic Lab Notebook, Request & Inventory Systems, Data Warehouse Systems, and data acquisition systems is a must.
- Direct experience with configuration and management of LabVantage LIMS
- Familiarity with Life Sciences laboratory instrumentation and software.
- Experience integrating LIMS with laboratory instrumentation and other enterprise software applications.
- Ability to translate business requirements/needs into software and laboratory instrumentation solutions
- Minimum 6 years of experience implementing and maintaining laboratory systems, working in a GxP environment with a focus on GMP and GLP
- Knowledge of cGMP and GcLP operations and practices
- An understanding of computer systems validation practices (GAMP).
- Experience designing and conducting system validations and familiarity with lab instrumentation/processes and project management is preferred.
- Experience with Pharmacokinetics, Pharmacodynamics, and PCRs, molecular biology, cell line engineering, and protein sciences is vital.
- Demonstrated ability to work independently and collaboratively on cross-functional teams.
- Excellent communication skills to bridge the gap between the business and IT
- Candidate must possess good time management skills and organizational skills.
- Ability to work on-site in Andover, MA or Columbus, OH
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-Hybrid
#LI-ES1
This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
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.
