Scientist

Shift

1st Shift M- F 9 - 5 (at site)

Description:

Process Validation Scientist - Official Title/Role

• Demonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing of large molecule biologics
• Lead Process Validation (Stage 3) activities including:
  • process validation strategies
  • protocols/reports review/approval
  • timely generation of Chemistry Manufacturing and Controls (CMC) documentation
  • collaboration between Manufacturing Sciences and Technology (MS&T), Manufacturing Regulatory and Quality
  • provides statistical support for product monitoring using techniques including statistical process control, process capability analysis, non-linear and linear regression and significant tests.
  • process investigation PV impact assessment strategies
• Collaborate with global process validation team
• Communicate CPV trends to Quality Management and CMC teams.
• Present/defend process validation packages and strategies during audits and inspections.
• Review/approve technical reports and deliver presentations utilizing sound compliance reasoning and interpretation of the available data

Essential for the role:

• Bachelor's Degree preferably in Science or Engineering. Master's Degree or PhD preferred.
• At least ten (10) years of overall experience in Scientific / Biotech / Pharmaceutical field with at least five (5) years of experience in Process Validation.
• Comprehensive knowledge PPQ and CPV regulatory expectations.
• Fundamental understanding of upstream and downstream process units for biopharmaceutical products.
• Broad understanding of Chemistry Manufacturing and Controls (CMC) activities and responsibilities with respect to Process Validation/Process Performance Qualificatio
• Knowledge of GMP manufacturing principles and documentation
• Proficient in statistical tools and techniques commonly used in the Biotech industry.
• Ability to apply critical thinking to solve problems and work independently
• Strong interpersonal and communication skills.

Preferred Experience

• Masters degree
• 6-10 years experience in biopharmaceutical Process Validation, Continued Process Verification role either as practitioner or Quality Assurance
• Strong technical writing and collaboration
• Regulatory experience is a plus
• Statistics experience is a plus