Engineer, RNA Process Development Job at Sarepta Therapeutics
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 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 Sarepta’s 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, study reports, SOPs, protocols, and work instructions
- Other duties as assigned
Desired Education and Skills Requirements:
- B.S. in chemistry/chemical engineering or related discipline with 0-2 years industry experience.
- Experience with GE AKTA FPLC and Unicorn software preferred
- Experience in solid phase synthesis techniques, ultrafiltration, lyophilization, and chromatography is a plus
- Knowledge of peptide and oligonucleotide conjugation is a plus
- 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
This position requires work on site at one of Sarepta’s facilities in the United States.
Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
Candidates must be authorized to work in the U.S.
Sarepta offers a competitive compensation and benefit package
Sarepta is an Equal
Opportunity/Affirmative
Action employer and participates in e-Verify
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