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Associate I, Gene Therapy Downstream

Company: Sarepta Therapeutics
Location: Burlington
Posted on: August 22, 2019

Job Description:

The Position:

The Associate I will help drive the development of Sarepta s Gene Therapy platform. Working as a downstream (purification) member of Gene Therapy group within Technical Operations department. He/she will be responsible for the contributing to the development, characterization, scale-up and transfer of cell based processes to generate viral vectors for therapeutic use.

Primary Responsibilities include:

* Execute purification studies with the goal of developing robust and scalable processes for gene therapy viral vectors

* Provides appropriate level of design input in the development of experimental plans, execution of experiments and the interpretation of scientific results

* (With assistance) draft technical reports and present findings to colleagues

* Ensure effective, high-quality, timely and appropriate documentation in laboratory notebooks

* Contribute to equipment procurement, laboratory set up and organization

* Contribute to a safe, efficient and effective lab environment with personal accountability

* Keep abreast of industry trends and technology through external entities such as conferences, publications and courses and contribute to the field through publications and poster sessions

Education and Skills Requirements:

* Bachelors or Masters in pharmaceutics, biology, biotechnology, chemical engineering, biochemistry, molecular biology or a related discipline with 0-2 years of pharmaceutical industry experience in process development

* General understanding of purification strategies for viral vectors (e.g. AAV, LV, etc.) used for gene therapy/vaccine applications preferred

* Experienced in scale-up studies in column chromatography, filtration (normal flow and tangential), centrifugation and gradient separation preferred

* Experienced with buffer screening studies, in-process pool hold evaluations and impurity clearance studies

* Experience in scale up, process design, DOE, process characterization, troubleshooting and cross organizational and external project collaboration preferred

* Solid communication and interpersonal skills to help build strong relationships across various drug discovery and development functions with specific examples of working cross functionally with quality, downstream, analytical, manufacturing and regulatory organizations

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

* Working knowledge of statistical design and modeling of experiments (i.e. DoE)

* Ability to participate in experimental design, study analysis and interpretation

* Ability to write summaries and technical reports, and presentation to cross functional teams

* Solves routine to moderately complex problems

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.

Keywords: Sarepta Therapeutics, Newton , Associate I, Gene Therapy Downstream, Healthcare , Burlington, Massachusetts

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