Process Engineer, Manufacturing & MS&T for AAV Gene Therapy

Taysha Gene Therapies; Morrisville (NC); Hybrid; USD 95,000 - 105,000; Full time

Benefits offered by this job

Stock options

ESPP program

Bonus program

401(k) with matching

Medical, dental, Vision benefits

Job summary

Taysha Gene Therapies is seeking a Process Engineer, Manufacturing and MS&T to contribute to development, optimization and continuous improvement of AAV-based gene therapy manufacturing processes.

The role provides technical expertise across the product lifecycle, from scale-up and tech transfer to commercial manufacturing support and troubleshooting, with hybrid work based in Morrisville, NC or remote in Baltimore, MD.

Qualifications

• Bachelor’s Degree in science or engineering required.
• 1–5 years of biotech/pharma manufacturing with direct cGMP experience.
• Knowledge of high-purity suspension-based AAV gene therapy operations preferred.
• Demonstrated ability to manage complex projects and priorities.
• Excellent written and oral communication skills.
• Self-starter with strong time management.
• Ability to travel up to 25%.

Responsibilities

• Oversee investigation and resolution of manufacturing issues including deviations and CAPAs.
• Collaborate with Taysha and CDMO groups to manage product lifecycle activities.
• Author/review risk assessments, process descriptions, control strategies, tech transfer docs.
• Review CDMO PFDs, MPRs, SOPs, Sample Plans, Protocols and Reports.
• Provide on-site manufacturing support at CDMO.
• Support MS&T activities in process development as needed.
• Identify and implement monitoring and control strategies for consistency.
• Support QA audits and regulatory inspections.

Skills

Communication

Project management

Time management

Travel willingness

Education

Bachelor's degree in science or engineering

Job description

Taysha Gene Therapies is seeking a Process Engineer, Manufacturing and MS&T to contribute to development, optimization and continuous improvement of AAV-based gene therapy manufacturing processes.

The role provides technical expertise across the product lifecycle, from scale-up and tech transfer to commercial manufacturing support and troubleshooting, with hybrid work based in Morrisville, NC or remote in Baltimore, MD.