Contract GMP Data Analyst Associate-2 at Sarepta Therapeutics in Burlington, Massachusetts

Job Description:

see attached job description

• Ensures that detailed and appropriate reviews of manufacturing batch documentation are conducted in a timely manner based on cross functional documentation review cycle timelines.


• Provides support for the development, construction, data input, and management of manufacturing process data collection templates contained within a validated data management system.


• Provides input for the design and establishment of data analysis tools to conduct process performance analyses and statistical in-process control models as delegated.


• Contribute to and support tech transfer initiatives, change control workflows, and continued process support/verification activities, as appropriate, by leveraging participation in the construction of performance trending summaries, models, and technical reports.


• Keep abreast of industry practices, methods, and tools for the analysis of multivariate process data through external entities such as publications and courses and introduce learnings to contribute to the refinement/development of effective MS&T group practices.

Education and Skills Requirements:

• Bachelors or Masters in pharmaceutics, biology, biotechnology, chemical engineering, biochemistry, molecular biology or a related discipline with minimum of 1-5 years of pharmaceutical industry experience in process development, manufacturing, and/or MS&T


• General understanding of cell culture modes of operation (adherent flatware, fixed bed, stirred tank bioreactors etc.) and purification modes of operation (TFF, AAVX, AEX, viral filtration etc.) used for gene therapy ((e.g. AAV, LV, etc.) and/or vaccine production is preferred

• Previous experience in supporting cGMP manufacturing and a good understanding of drug substance/drug product manufacturing principles and unit operations

• Experience in solution chemistry or formulating cell culture mediums and purification buffers


• Must possess technical troubleshooting experience in a bioprocess setting


• Solid communication and interpersonal skills to help build strong relationships across various business functions with specific examples of working cross functionally with process development, quality, analytical, manufacturing and regulatory organizations


• Familiar with GxP requirements (e.g. cGMP) and working in a regulated field is preferred

• Previous experience entering, verifying and correcting data in a validated data management system preferred


• Proficiency in applying statistical principles with the use of software platforms and previous experience constructing statistical in-process control/trending models a plus

• Must possess strong documentation practices and possess the ability to write summaries, technical reports, and construct presentations to cross functional teams and/or program stakeholders


• Experience with quality systems, risk-based tools, and process monitoring data applications a plus


• Excellent time and project management skills, detail-oriented and ability to work on multiple projects simultaneously

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.