### **Position:** MSAT Tech Transfer Engineer

**Location:** Wilson, NC

### **Job Description**

The Manufacturing Science and Technology (MSAT) department manages the process technology platform strategy to produce biotherapeutics in the BioProcessing Facility in Wilson, North Carolina. The team is responsible for Process Validation, Thermal & Cleaning Validation, Equipment Standardization for New Product Introduction (NPI), Process Analytics implementation, and Life Cycle Management (LCM) of commercial manufacturing processes.

### **Key Responsibilities**

• Actively engage with the MSAT team to deliver successful Tech Transfer activities for Downstream processes and Process Analytics implementation in accordance with Good Manufacturing Practices (GMP).

• Lead Tech Transfer activities for new and commercial products, including implementation of new technologies and digital tools for downstream manufacturing.

• Plan, document, and execute process validation studies.

• Coordinate and execute Downstream process lifecycle management activities for new equipment, processes, and site startup initiatives in compliance with US/EU regulations and company procedures.

• Coordinate process improvement projects, commercial product scale-up initiatives, and technical transfer activities to ensure successful implementation.

• Provide second-line technical support to Manufacturing Operations and technical guidance for process improvement projects and investigations.

• Track and resolve exceptions, events, and nonconformances during MSAT activities.

• Coordinate and prioritize MSAT activities in alignment with manufacturing and project schedules.

• Implement, qualify, and maintain Process Analytical Technology (PAT) tools (e.g., Raman spectroscopy, capacitance probes, soft sensors) for real-time monitoring of upstream and downstream CQAs and CPPs.

• Integrate PAT instrumentation with manufacturing data systems to support process control, process robustness, and continuous process verification.

• Analyze process data to identify trends, deviations, and sources of variability across biologics manufacturing operations.

• Perform statistical modeling, multivariate analysis (PCA/PLS), and batch trajectory analytics to support investigations, Continued Process Verification (CPV), and continuous improvement initiatives.

• Support model lifecycle activities, including development, validation, documentation, and ongoing performance monitoring in a GMP environment.

• Author modeling-related documentation, including model development reports and analysis summaries.

• Prepare, review, and approve technical documents including CAPAs, change controls, investigations, protocols, reports, and SOPs.

• Compile technical information from contractors, suppliers, and cross-functional departments to develop technical reports.

• Complete required training to fulfill the responsibilities of the Tech Transfer Engineer role.

• Participate in cross-functional project teams and investigation teams as required.

### **Qualifications**

#### **Education**

• Bachelor's degree in Life Sciences, Engineering, Biology, Biochemistry, or a related scientific field (required).

#### **Required Experience & Skills**

• Minimum 4 years of experience in the pharmaceutical manufacturing industry or other regulated industry.

• Minimum 2 years of experience in Technical Transfer processes.

• Experience with process analytics and statistical modeling.

• Strong knowledge of FDA, EMEA, and other applicable regulatory requirements.

• Ability to collect, process, and analyze data to support technical studies and decision-making.

• Excellent verbal and written communication skills with the ability to collaborate effectively with internal and external stakeholders.

• Proficiency in Microsoft Office Suite, Excel, and SAP.

• Ability to interact effectively across multiple organizational levels and perform well under pressure while managing competing priorities.

• Strong analytical, problem-solving, adaptability, and flexibility skills.

• Ability to work independently with minimal supervision, demonstrating effective prioritization and time management.

#### **Preferred Qualifications**

• Experience supporting New Product Introduction (NPI) and process validation in a downstream manufacturing environment.

• Ability to lead cross-functional teams and effectively manage complex projects and organizational change.