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Associate I, Process Development

Company: Sarepta Therapeutics
Location: Andover
Posted on: November 24, 2020

Job Description:

This position is part of a team focused on all aspects of the RNA platform (PMO, PPMO, and PMOx) based drug substance process development, to support products in early stage development. The primary focus of the position will be executing downstream process development, optimization, and process characterization projects to advance the Sarepta RNA platform technologies. The position will also participate in a cross-functional development team to advance production activities to support technology transfer and GMP manufacturing for IND enabling activities. Primary Responsibilities Include: - Develop robust, well-characterized, and high quality downstream manufacturing processes - Plan and execute experiments at bench scale to support scale up and optimization of Sareptas PMO and PPMO downstream platform - Design and execute process development studies to develop a thorough understanding of operating and performance parameters - Engage in troubleshooting sessions for processes and products manufactured in-house and at CMOs - Perform technical review of executed Batch Production Records from CMOs during Technology Transfer - Evaluate and improve current manufacturing processes and workflows based on risk and impact assessments - Consistently demonstrate an ability to manage a diverse workload to complete individual assignments and group projects according to project schedules and timelines - Author and review technical documents such as MBRs, SOPs, protocols, work instructions, and development reports - Other duties as assigned Education and Skills Requirements: - B.S. in chemistry/chemical engineering or related discipline with 1-3 years industry experience or M.S. with 1+ years of experience - Experience with GE AKTA FPLC and Unicorn software preferred - Experience in solid phase synthesis techniques, ultrafiltration, lyophilization, and chromatography preferred - Experience with peptide and oligonucleotide conjugation preferred - Experience in process design utilizing QbD and DoE principles is a plus - Experience with analytical techniques such as HPLC, MALDI-TOF MS, DSC, DLS, SEC-MALS, rheometry, and fluoremetry are a plus - Experience with chromatography method development for RP, IEX, SEC, and HIC is a plus - Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results - Demonstrates effective written and verbal communication skills - Able to handle multi-task workload and perform duties in a fast-paced environment - Operate as part of a team to meet assigned goals 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, Boston , Associate I, Process Development, Other , Andover, Massachusetts

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