Lead Tech Transfer Engineer

Job Responsibilities:

• Support process validation and technical transfer for pharmaceutical and biologic fill-finish operations

• Design and execute studies for process development, scale-up, optimization, and robustness

• Author and review technical documentation, including protocols, reports, and batch records

• Lead technical transfer projects and serve as subject matter expert (SME) for internal and external stakeholders

• Collaborate cross-functionally with quality, analytical, production, engineering, and project management teams

• Provide technical support to GMP manufacturing, including troubleshooting and deviation investigations

• Translate client discussions into actionable project plans and contribute to proposal and study design

• Ensure compliance with cGMP, CGDP, and regulatory expectations in all activities

• Conduct Quality by Design (QbD) studies and validation protocols to support regulatory submissions

• Deliver training on new processes and contribute to a culture of compliance and technical excellence

Qualifications:

• Bachelor’s degree in Science or Engineering

• Minimum of 7 years of relevant experience in pharmaceutical manufacturing or process development

• Experience with sterile fill-finish operations, including aseptic or isolator-based manufacturing

• Strong understanding of process design, scale-up, and statistical analysis for process control

• Proven leadership in managing cross-functional technical projects

• Proficiency in authoring GMP-compliant protocols, reports, and risk assessments

• Excellent communication and collaboration skills, including client-facing interactions

• Strong decision-making, troubleshooting, and problem-solving skills in high-pressure settings