Scientist I, Early Stage Process Development

Primary Responsibilities Include:

• Develop robust, well-characterized, high quality and high yielding upstream production processes for gene therapy viral vectors using mammalian adherent or suspension cell lines under the direction of senior team members
• Plan and execute mammalian cell culture experiments at bench scale (shake flask, rocking bioreactors, AMBR15, and 1-50L SUB’s)
• Design and execute process development studies to develop a thorough understanding of operating and performance parameters
• Identify and implement operational improvements and novel technologies to improve upstream yield and key quality attributes of viral vectors
• Prepare and review protocols, technical reports and SOPs for regulatory and tech transfer purposes
• Participate and influence a cross-functional development team to advance production activities
• Perform process analysis and trend process performance
• Participate in technology transfer to manufacturing partners and provide oversight in process scale-up
• Contribute to a safe, efficient and effective team environment with personal accountability
• As a member of GTCOE work seamlessly with cross functional stakeholders within Tech Ops particularly Vector Core, Downstream and Analytical development team to facilitate translational research and to advance early stage gene therapy programs

Education and Skills Requirements: 

• Advanced degree in scientific disciple required. Ph.D. in Bioengineering, Pharmaceutical Science, Biology, Biochemistry or related degree strongly preferred. 1-3 years of related experience.
• Demonstrated expertise in mammalian cell culture techniques for adherent or suspension culture systems in batch and fed-batch modes. Previous experience in stable cell line development is a plus
• Previous experience in media development for improving cell culture performance is desired
• Experience in upstream techniques for production of biologics preferably with the use of bioreactors (rocking, stirred-tank) is highly desirable. Viral vectors production experience a plus
• Experience in basic biochemistry laboratory techniques such as qRT-PCR, SDS-PAGE, Western blot, ELISA, etc. is expected
• Experience in process design utilizing QbD and DoE principles via high-throughput approaches for process optimization is desirable.
• Proficient in Microsoft office applications (Word, Excel, Powerpoint, Outlook) and knowledge of statistical software applications such as JMP, GraphPad Prism, etc. is a plus
• Ability to think critically, and demonstrate troubleshooting and problem-solving skills
• Self-motivated with a strong sense of ownership in areas of responsibility and willingness to accept temporary responsibilities outside of initial job description
• Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.
• Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team

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.