Process Engineer, Manufacturing and MS&T

Taysha Gene Therapies • Morrisville, NC

6d • Hybrid

About The Position

The Process Engineer, Manufacturing and MS&T, is responsible for contributing to the development, optimization and continuous improvement of manufacturing processes. This role ensures the successful and compliant production of high quality AAV-based gene therapy products by providing scientific and technical expertise throughout the product lifecycle, from process scale-up and technology transfer to commercial manufacturing support and troubleshooting. This position will provide oversight of manufacturing activities at Taysha’s selected CDMO for investigational and commercial drug substance and drug product to ensure products and intermediates are delivered to meet Taysha’s product specifications, quality, regulatory and timeline requirements.

Requirements

• Bachelor’s Degree in science or engineering required.
• 1-5 years’ experience in the biotechnology or pharmaceutical manufacturing industry with direct experience in cGMP manufacturing or manufacturing sciences.
• Demonstrated ability to manage complex projects and competing priorities.
• Excellent written and oral communication skills.
• A proven self-starter with excellent time management skills.

Nice To Haves

• Knowledge of high-purity suspension-based AAV gene therapy manufacturing process operations preferred.

Responsibilities

• Oversee investigation, evaluation and resolution of manufacturing issues, including evaluation of deviations, technical changes and CAPAs to materials, manufacturing processes and product specifications.
• Liaise and collaborate with Taysha and CDMO functional groups to ensure compliant management of product lifecycle activities including PPQs, comparability, CPV, change controls, tech transfers (development to manufacturing, site-to-site), etc.
• Author/review/approve risk assessments, process descriptions, control strategies, tech transfer documentation, regulatory submission documentation and other related MS&T documentation required for manufacture of process intermediates, drug substance and drug product.
• Review/approve CDMO PFDs, MPRs, SOPs, Sample Plans, Assessments, Protocols and Reports in support of clinical and commercial supply manufacturing.
• Provide in-person plant support during manufacturing at CDMO.
• Provide Manufacturing/MS&T technical support to process development activities as required.
• Identify and implement process monitoring and control strategies to ensure manufacturing consistency and drive improvements in efficiency and quality.
• Contribute to the development and improvement of department-level and cross-functional goals and objectives, Standard Operating Procedures (SOPs), business processes, systems, and tools.
• Support and participate in Quality Assurance audits and regulatory inspections.

Benefits

• Individual Stock Option awards
• ESPP program
• eligibility to participate in performance bonus program
• company-sponsored 401(k) with matching contribution
• eligibility for medical, dental, vision and prescription drug benefits
• a generous vacation/holiday schedule

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level