Job Description

What You’ll Do

Technology Transfer

• Lead and coordinate the full lifecycle of tech transfer from development to manufacturing.
• Collaborate with cross-functional teams to ensure all process knowledge and documentation are effectively communicated to the CMO.
• Conduct facility fit assessments and system walk-downs to validate equipment and process readiness.

Process Engineering

• Manage upstream processes, particularly mammalian cell culture at 2000L scale in single-use or stainless-steel bioreactors.
• Oversee downstream purification operations including chromatography, ultrafiltration, and sterile filtration.
• Support implementation of PAT (Process Analytical Technology) tools to enable real-time process monitoring and control.

GMP and Validation

• Draft and execute IQ/OQ/PQ protocols for new or transferred equipment and systems.
• Support QA in handling change controls, deviations, and CAPAs aligned with FDA and ICH guidelines.
• Ensure compliance with all applicable cGMP regulations and internal quality systems.

Data & Documentation

• Review and analyze process data to identify trends, troubleshoot issues, and support continuous improvement.
• Prepare high-quality documentation including SOPs, validation reports, and batch records.

Cross-functional Collaboration

• Act as a liaison between internal technical teams and external CMOs to ensure alignment on project deliverables.
• Participate in joint project planning, risk assessments, and technical discussions.

Required Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• Minimum 5 years of experience in process engineering within the biopharmaceutical industry , with hands-on experience in mAb manufacturing .
• Direct experience in technology transfer to CMOs.
• Strong understanding of GMP requirements and bioprocess validation.
• Proficient in working with large-scale bioreactors (2000L) and downstream unit operations.

Preferred Qualifications

• Familiarity with single-use technologies and disposable bioprocessing systems.
• Knowledge of regulatory submissions (e.g., IND, BLA).
• Experience with statistical tools for process monitoring and optimization (e.g., JMP, Minitab).

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