Principal Process Validation Scientist

Principal Process Validation Scientist

Requirements

• BS/BA in Life Sciences; Chemistry, Biology & Biochemistry is preferred
• 8+ years of relevant experience or equivalent combination of education & experience
• Understanding of antibody manufacturing processes
• Solid understanding of Microsoft Suite (Word, Excel, PowerPoint)

Responsibilities

• Provides technical support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities
• Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities
• Analyzes information and data from development through late stage-characterization as well as at-scale manufacturing history
• Liaises with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle
• Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge
• Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines
• Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed
• Applies engineering principles to the development and execution of process controls and validation strategies
• Analyzes data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control
• Develops and monitors health of the business using key performance indicators
• Develops and improves cross-functional business and manufacturing processes
• Works effectively and efficiently in a team-oriented environment
• Provides support to laboratory studies and/or studies performed at manufacturing scale

Preferred Qualifications

• Enjoy working in a fast-paced environment and have the innate ability to balance multiple projects, prioritize them and execute them independently
• Can take on new and sometimes ambiguous challenges and learn quickly
• Able to work in a team environment but can also take ownership of large technical reports and projects
• Can develop and drive scientific and/or business-related improvement ideas