Research Associate II, Gene Therapy Process Development , In Process Analytics

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Company :
Sarepta Therapeutics

Location :
Burlington, Massachusetts

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Description :
The Research Associate II will support the development of Sarepta s Gene Therapy platform. Working as a member of Gene Therapy group within Technical Operations department, he/she will support the implementation of in-process analytical test methods for use in the development of gene therapy products. The individual will execute established test methods to better characterize product and impurities over the course of development and will contribute to in process analytical method development, establishment, optimization and qualification. Under direction of a Senior Analytical Scientist, Primary Responsibilities include: * Provide routine testing support to enable PD project progression and work with technical teams to interpret results in a timely fashion. * Contribute to develop, establish, set up, optimization, and qualify analytical methods that is suitable to in process sample analysis, especially to cell and plate based analytical methods to support upstream and downstream process development. * Participate in evaluation and implementation of new technologies to improve quality and robustness of sample analysis * Participate in project related teams and other internal collaborations. * Review analytical data from the other analyst and prepare work protocols. * Troubleshoot routine technical challenges, and contribute to their resolution. * Analyze and communicate experimental results both orally and in written reports to colleagues and management. * Ensure effective, high-quality, timely and appropriate documentation in laboratory notebooks and internal Technical Reports. * Contribute to equipment procurement and maintenance, laboratory set up and organization. * Contribute to a safe, efficient and effective lab environment with personal accountability. Education_And_Skills_Requirements * BS/BA in biochemistry, chemistry, biology or a related discipline with 2- 5 years of pharmaceutical industry experience in gene therapy or related disciplines OR MS degree in related field with 0-3 years related experience * Strong Hands-on experience in a wide array of bioanalytical techniques such as ddPCR, SDS-PAGE, ELISA, Western Blot-based methods are required, familiarity with qPCR, Capillary Electrophoresis (CE) and HPLC/UPLC is also desirable. * Excellent bench skills with attention to details and high standards for data integrity and quality * Direct hands-on experience in analytical development or QC of gene therapy products or related pharmaceutical products is highly preferred. * Solid communication and interpersonal skills to help build strong cross- functional relationships * A basic understanding of drug substance manufacturing principles and unit operations * A keen awareness in cGMP, cGLP, regulatory guidelines related to pharmaceutical analytical development and quality control. * Working knowledge of statistical design and modeling of experiments in assay design, development, qualification and validation. * Ability to write summaries and technical reports, and presentation to cross-functional teams * Ability to troubleshoot and solve technical issues * Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion 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. Show moreShow less