MSAT Sr. Engineer

MSAT Sr. Engineer

The MSAT Sr. Engineer will provide technical leadership for cell therapy manufacturing operations, ensuring processes are robust, scalable, and compliant with GMP standards. This role is pivotal in technology transfer, process improvement, facility start-up, and regulatory readiness, supporting both clinical and commercial production.

Responsibilities

• Lead or support initiatives to enhance process robustness and GMP compliance.
• Contribute to construction, qualification, and start-up of new manufacturing facilities.
• Author, review, and approve technical documentation including SOPs, protocols, and reports.
• Act as MSAT liaison across development, manufacturing, QA/QC, supply chain, and vendors.
• Provide hands-on support for cell processing operations.
• Lead investigations for deviations and implement CAPAs.
• Analyze process data and present findings to stakeholders.
• Ensure adherence to cGMP, safety standards, and SOPs.
• Support regulatory submissions and act as a subject matter expert during audits.
• Identify and mitigate manufacturing risks.
• Assess and qualify raw materials for reliability and supply continuity.

Essential Skills

• Strong understanding of cell therapy manufacturing processes.
• GMP compliance and regulatory readiness.
• Experience with technology transfer and process validation.
• Proficiency in aseptic processing and cleanroom operations.
• Expertise in root cause analysis and CAPA implementation.
• Ability to collaborate cross-functionally.
• Technical writing and documentation skills.
• Data analysis and risk management capabilities.
• Familiarity with MES/ERP systems.
• Knowledge of Quality by Design (QbD) and ICH guidelines.

Additional Skills & Qualifications

• Bachelor's or Master's in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• 8+ years (Bachelor's) or 6+ years (Master's) in MSAT or biopharma manufacturing.
• Experience with process lifecycle management and validation.
• Experience with regulatory submissions and audits.
• Excellent problem-solving and communication skills.
• Flexibility to support weekend operations as needed.

Work Environment

Work in GMP-compliant manufacturing facilities with cleanroom environments. Engage in cross-functional collaboration with R&D, QA/QC, and the supply chain. The work setting is fast-paced and dynamic, with hands-on technical engagement. Occasional weekend support may be required. Join a pioneering team advancing cell therapy for kidney disease in an innovative environment with cutting-edge technology.

Job Type & Location

This is a permanent position based out of Winston Salem, North Carolina.

Pay and Benefits

The pay range for this position is $85000.00 - $150000.0yr.

Medical, Dental, Vision Plans: Multiple coverage levels including individual, spouse, children, and family. Options include basic and high-deductible plans with competitive premiums, 401K, PTO and Holidays.

Workplace Type

This is a fully onsite position in Winston Salem, NC.

Application Deadline

This position is anticipated to close on Oct 16, 2025.