Lead Analyst, Research Operations - Cambridge, United States - Sarepta Therapeutics

Sarepta Therapeutics

Verified Company

Cambridge, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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 jobspecific 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 13 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, fastpaced 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 multidisciplinary teams, using strong organizational, communication, and interpersonal skills to facilitate discussions and decisionmaking
Ability to work effectively in a flexible environment, including effectively managing distancebased 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 problemsolving 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.