Lead Analyst, Research Operations

2 weeks ago

Cambridge, United States Sarepta Therapeutics Full time

Sarepta Therapeutics is seeking a motivated individual to perform scientific computing, system analysis and administrative functions to support business operations. This position engages with Sarepta’s multidisciplinary researchers including study directors, pathologists, and other laboratory staff at the Ohio Genetic Therapies Center of Excellence.

This role requires previous experience in an IT role working with information technology/laboratory systems in a biotech/pharmaceutical company.

Primary Responsibilities Include:

- Managing licenses and providing oversight of user account management following established procedures
- Partnering on business strategy and driving process, technology, and use of data across the organization
- Assisting with reporting results obtained from data generated from Provantis, as assigned
- Functioning as the ad hoc archivist for electronic data, as assigned
- In conjunction with Validation staff, facilitating the implementation of systems and assisting with validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design Specifications, IQ/OQ/PQ Protocols, Traceability Matrices, SOPs, and other documentation
- Managing and actively participating in the Change Control process utilizing the established electronic Quality Management System workflows and procedures
- Completing and maintaining all job-specific training required to competently perform assigned job duties
- Ensuring functional work activities are conducted in compliance with applicable regulatory and technology requirements, and Sarepta policies and procedures
- Flexibility and adaptability to additional projects and responsibilities as assigned to support the overall goals of the company

Desired Education and Skills:

- AS degree in scientific discipline with 10+ years of experience, BS degree in scientific discipline with 5+ years of experience, or MS degree in scientific discipline with 1-3 years of experience in the healthcare, biotech/pharmaceutical industry or equivalent
- 5+ years of experience supporting or implementing software systems, preferably in a scientific GxP environment
- Experience with one or more of the following systems is preferred: HALO Image Analysis Platform, Provantis integrated preclinical software solution, and Aperio Digital Pathology Software suite
- Desire to work in a dynamic, collaborative, fast-paced team environment and to make a difference in the lives of people through innovative medicines
- Demonstrated experience managing implementation of research studies under GCP/GLP compliance
- Experience with 21CFR Part 11, regulatory compliance, and validation standards
- Capacity to work effectively either independently, or on multi-disciplinary teams, using strong organizational, communication, and interpersonal skills to facilitate discussions and decision-making
- Ability to work effectively in a flexible environment, including effectively managing distance-based working relationships
- Experience with creating and maintaining standard operating procedures and configuration documents to meet compliance requirements
- A strong record of demonstrating critical thinking and creative problem-solving skills
- The ability to successfully manage projects and timelines, organize and track complex information, prioritize accordingly, and quickly adjust to shifting priorities and demanding timelines when necessary
- Ability to work extended hours as needed including, but not limited to, weekend and holiday coverage, occasionally on short notice

This position requires work on-site a minimum of two business days per week, and additionally as needed, at one of Sarepta’s facilities in the United States.

LI-Hybrid

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.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

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