Senior Associate, Research Operations - Validation

This individual will be a member of the local quality team that supports preclinical and clinical genetic therapy research functions. This individual will be responsible for driving the equipment and method implementation process including IQ/OQ/PQ, hardware/software, and method validations. The candidate will have a strong scientific and technical background, a clear understanding of the individual requirements for equipment induction and method validation, and the experience to manage these activities. The candidate will work closely with IT and CSV staff, as well as scientific staff.

Primary Responsibilities Include

• Ensuring timely closure of required change controls to align with business needs and corporate procedures
• Reviewing and providing input on method validation protocols to ensure scientific rigor
• Reviewing internal validation test scripts, plans, and reports
• Reviewing and approving vendor-supplied qualification documentation
• Maintaining the integrity of data, both paper and electronic, generated during equipment induction and maintenance
• Managing equipment decommissioning activities
• Acting as asset owner in BMRAM, approve new induction requests, change controls, and work orders
• Performing all activities in compliance with GLP regulations and corporate SOPs
• Maintaining current and accurate inventories of all equipment and software versions, including qualification status
• Managing equipment induction activities including selection, procurement, qualification, and CSV
• In collaboration with equipment requestors and IT-Lab Systems, ensuring completion of compliant and accurate induction documentation (e.g., RBA, URS, Config/Design Specs, IQ/OQ/ PQ, user SOP)

Desired Education And Skills

• Experience in assay method validations
• Minimum of 2 years of experience in managing equipment commissioning, including CSV
• Ability to multi-task and adapt quickly to a changing environment
• B.S. degree in Biology, Molecular Biology, Chemistry, or related field
• Minimum of 5 years of experience in a quality role, preferably in a GLP environment
• Excellent planning and problem-solving skills
• Ability to manage multiple projects at one time
• Excellent writing and communication skills
• Project management skills preferred
• Ability to work cross-functionally with people at all levels of the organization
• Experience in immunology, molecular genetics, histology, and/or nonclinical studies is preferred
• Ability to work with minimal supervision

This position requires work on site at one of Sarepta’s facilities in the United States.

The targeted salary range for this position is $76,000 - $95,000 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.