Engineer, Gene Therapy Process Development

Sarepta Therapeutics • Burlington, MA

287d • $76,000 - $95,000

About The Position

The engineer will make critical contributions towards the development and lifecycle management of Sarepta's Gene Therapy platform within the downstream process development team. They will be primarily responsible for contributing to the development, characterization, optimization, scale-up and transfer of the downstream processes to generate purified viral vectors for therapeutic use. This individual will be performing lab-based downstream process development activities.

Requirements

• B.S. degree in Biochemistry, Biotechnology, Chemical Engineering, or similar with 2+ years of lab experience.
• M.S. in Biochemistry, Biotechnology, Chemical Engineering, or similar with 1+ years of related experience.
• Hands-on experience or education in concepts, practices and procedures of biologics process development (e.g. mAb, AAV, LV, etc.).
• Strong understanding of chromatographic separation is preferred.
• Hands-on experience with AKTA purification systems and common TFF & filtration systems.
• Familiarity of common analytical laboratory practices like PCR, SEC, ELISA assays.
• Strong ability to apply basic engineering principles and statistical tools for troubleshooting and data analysis.
• Experience with statistical software like JMP or Statistica is preferred.
• Experience in writing, revising, and following SOPs and MBRs preferred.
• Computer skills including Microsoft Excel, Word and Outlook.
• Strong organizational skills and attention to detail are necessary.
• Able to multi-task and perform effectively under tight deadlines.
• Effective communication and listening skills are required.
• Familiar with GxP requirements (e.g. cGMP) and working in a regulated field is preferred.
• Ability to lift and carry up to 50 lbs.

Responsibilities

• Independently perform clarification, filtration (Normal & Tangential), and chromatography operations with minimal guidance.
• Generate experimental study designs with some guidance.
• Independently conduct sample submission, data compilation and analysis of experimental data sets.
• Prepare solutions, buffers, and media as needed.
• Support process scale-up and technical transfer as needed.
• Contribute to downstream development operational improvement initiatives.
• Maintain lab equipment, inventory management and laboratory organization.
• Collaborate cross functionally with teams across departments.
• Adhere to company and department SOPs on lab operations and good documentation practice, and EHS lab safety regulations.
• Support drafting and review of technical reports, SOPs as appropriate under general supervision.

Benefits

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree