Principal Engineer - Full-time / Part-time

Burlington, Massachusetts, United States

Sarepta is seeking a highly motivated leader to join the gene therapy manufacturing sciences and technology (MS&T) group. The Principal Engineer of Data Analytics is responsible for the technical leadership and oversight of the Manufacturing Sciences and Technology Data Analytics team supporting late stage clinical and commercial drug product manufacturing.

Primary Responsibilities Include:

• Collaborate with IT, RNA MS&T, QA, QC and Other function areas within broad Technical Operations organization to establish the process data analytics strategy for GT MS&T.
• Define data system alignment strategy across Sarepta’s RNA and gene therapy manufacturing network.
• Select and deploy enterprise data system and analysis software tools based on a thorough understanding of user requirements and business context.
• Provide data analytics SME support for complex data analysis requests, such as periodic batch data review, CPV, critical investigations or continuous improvement initiatives.
• Maintain awareness of external trends and represents Sarepta at industry forums.
• Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and inform/escalate to senior management when necessary.

Education and Skills Requirements:

• Requires a BS, MS or PhD in Engineering (or other relevant discipline) with a minimum of 10 years of experience in Data Analytics supporting biopharmaceutical manufacturing.
• The preferred candidate will have solid experience in a cGMP-regulated environment, preferably gained through direct support of late stage clinical and commercial operations.
• Knowledge of ICH and world-wide Health Authority guidelines, a thorough knowledge of data analytical tools, and sound understanding of data validation and biopharmaceutical manufacturing.
• Ability to engage and motivate teams, outstanding ability to communicate and build collaborations.
• Experience leading and managing cross-functional project teams.

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.

Job Information

• Job ID: 53865851
• Location:
  Burlington, Massachusetts, United States
• Position Title: Principal Engineer, Data Analytics

Sarepta Therapeutics, headquartered in Cambridge, Massachusetts, is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates. For more information, please visit us at www.sarepta.com.

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