Job Details
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.