Demonstrating Upstream and Downstream Unit Operations Knowledge:
Utilize your understanding of bioprocessing principles to optimize cell culture and purification processes.
Ensure efficient transfer of processes from lab scale to commercial production, maintaining quality and yield.
Leading Process Validation Activities:
Develop and implement robust process validation strategies.
Review and approve validation protocols and reports, ensuring compliance with regulatory requirements.
Generate timely Chemistry Manufacturing and Controls (CMC) documentation.
Collaborate closely with MS&T, Manufacturing Regulatory, and Quality teams to ensure alignment and compliance.
Provide statistical support for product monitoring using various techniques like statistical process control, process capability analysis, and regression analysis.
Develop strategies for investigating process deviations and their impact on process validation.
Collaboration and Communication:
Work closely with the global process validation team to share best practices and ensure consistency.
Communicate trends in Continued Process Verification (CPV) to Quality Management and CMC teams.
Present and defend process validation packages and strategies during audits and inspections.
Qualifications:
Bachelor's Degree in Science or Engineering (Master's or PhD preferred).
5-7 years of experience in the pharmaceutical or biotech industry
previous process validation experience
Comprehensive knowledge of PPQ and CPV regulatory expectations.
Strong understanding of upstream and downstream bioprocessing units.
Familiarity with CMC activities related to Process Validation/Performance Qualification.
Proficiency in statistical tools and techniques used in the Biotech industry.