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Principal Research Associate MS&T DP - Validation - Job Opportunity at Moderna, Inc.

Melbourne, Australia
Full-time
Senior
Posted: May 1, 2025
On-site
AUD 140,000 - 180,000 per year based on Melbourne market rates for senior validation roles in biotech

Benefits

Comprehensive healthcare with premium coverage
Flexible Lifestyle Spending Accounts with personalized wellness options
Premium fitness and wellness program access
Industry-leading family planning and adoption benefits
Extended paid time off including sabbatical and global recharge days
Competitive retirement savings and investment options
Location-specific perks package

Key Responsibilities

Lead strategic validation and technology transfer initiatives for drug product manufacturing
Drive quality system implementation and compliance standards
Spearhead process optimization and continuous improvement programs
Manage cross-functional technical investigations and risk assessments
Direct documentation and SOP development
Oversee training program development and implementation
Lead technical support for critical manufacturing operations
Drive data-driven decision making and performance monitoring

Requirements

Education

Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field

Experience

3-5 years of experience in biotech or pharmaceutical industry

Required Skills

Sterile manufacturing operations expertise Technical writing and documentation Process validation knowledge Statistical analysis capabilities Investigation and root cause analysis Strong communication skills English language proficiency
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Sauge AI Market Intelligence

Industry Trends

mRNA technology is experiencing unprecedented growth with expanding applications beyond vaccines into therapeutics Increasing focus on local manufacturing capabilities in Asia-Pacific region for biopharmaceuticals Rising demand for validation specialists with next-generation therapeutic experience Growing integration of AI and digital tools in validation processes

Role Significance

Likely leads a team of 3-5 direct reports with matrix management of 10-15 stakeholders
Senior technical position with significant influence on quality systems and operational excellence

Key Projects

New facility validation and qualification programs Technology transfer from global manufacturing sites Process optimization and continuous improvement initiatives Regulatory compliance and inspection readiness projects

Success Factors

Deep understanding of mRNA manufacturing and regulatory requirements Strong leadership skills with ability to influence cross-functional teams Strategic thinking with focus on operational excellence Advanced problem-solving capabilities for complex technical challenges Excellent stakeholder management across global operations

Market Demand

Very High - Critical shortage of experienced validation specialists in advanced therapy medicinal products (ATMPs) sector

Important Skills

Critical Skills

mRNA/LNP manufacturing expertise Validation strategy development Risk assessment and management Technical writing and documentation Cross-functional leadership

Beneficial Skills

AI and digital systems knowledge Lean Six Sigma methodologies Project management Regulatory affairs understanding Change management expertise

Unique Aspects

Opportunity to establish validation systems in new facility
Work with cutting-edge mRNA technology
Global exposure with significant career growth potential
Involvement in pioneering biotech manufacturing in Australia

Career Growth

2-4 years in role before advancement opportunity, depending on business growth and performance

Potential Next Roles

MS&T Director Validation Head Technical Operations Director Quality Systems Director

Company Overview

Moderna, Inc.

Global leader in mRNA technology with rapid expansion in Asia-Pacific region

Pioneer in mRNA therapeutics with strong market position and extensive development pipeline
Strategic expansion into Australia with focus on commercial operations and manufacturing capabilities
Fast-paced, innovation-driven environment with emphasis on technical excellence and global collaboration
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