Principal Research Associate MS&T DP - Validation
Description
This role involves joining Moderna's pioneering team in Melbourne, Australia, to establish Drug Product (DP) MS&T activities at the Clayton site. The individual will act as a technical specialist, ensuring robust validation practices, technology transfers, continuous process verifications, investigations, and change management for a new drug product manufacturing line. The position aims to develop compliant, high-quality systems and processes to deliver mRNA products for local and export markets, while contributing to the site's technical leadership and championing quality culture.
What We're Looking For
Lead formulation, fill/finish, visual inspection, packaging, and related process validation and tech transfer activities.,Ensure manufacturing alignment with mRNA/LNP platform standards, author and review cGMP documentation.,Perform risk assessments, generate SOPs, and establish training programs.,Ensure robust validation practices, technology transfers, continued process verifications, investigations, and change management.,Drive the development of compliant, high-quality systems and processes.,Champion quality culture and contribute to the site's technical leadership.
Ideal Candidate
Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.,A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on sterile manufacturing operations.
Minimum Education
Bachelor's Degree or Master's Degree
Hard Skills
Soft Skills
Benefits
Moderna provides comprehensive support for its employees and their families. While a specific list of benefits is not publicly available, the company emphasizes its commitment to the well-being of its team. Benefits include paid time off for volunteering and support for community career development.
Special Commitments
This position is site-based, requiring you to be at Moderna's site full-time; this position is not eligible for remote work.
Also Available At
About the Company
Moderna, Inc.
Moderna is a biotechnology company pioneering a new class of medicines made of messenger RNA (mRNA). The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.
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