- 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.
- Bachelor's Degree preferably in Science or Engineering. Master's Degree or PhD preferred.
- 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 Qualification
- 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.
- BS/Master's degree 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.
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Scientist - Frederick, United States - Pyramid Consulting, Inc
Description
Immediate need for a talented Scientist - Process Validation Scientist. This is a 12+ Months Contract opportunity with long-term potential and is located in Frederick, MD (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID:
Pay Range: $45 - $50/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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