Jobs in Maryland 2026 (Now Hiring) - Smart Auto Apply
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Process Engineer, Manufacturing and MS&T
$95,000 - $105,000 / year
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Overview
Job Description
- 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.
- 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.
- Knowledge of high-purity suspension-based AAV gene therapy manufacturing process operations preferred.
- Demonstrated ability to manage complex projects and competing priorities.
- Excellent written and oral communication skills.
- A proven self-starter with excellent time management skills.
- Ability to travel up to 25% at times.
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