Internal Title: Process Validation Scientist

Duration: 11-month contract

Onsite in Frederick, MD

Responsibilities:

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.