Principal Research Associate MS&T DP - Validation
Description
The Principal Research Associate, MS&T - Validation, will be responsible for establishing Drug Product (DP) Manufacturing Science and Technology activities at Moderna's Clayton, Australia site. This role involves serving as a technical specialist to ensure robust validation practices, manage technology transfers, conduct continued process verifications, lead investigations, and oversee change management for a new drug product manufacturing line. The specialist will develop compliant, high-quality systems and processes to deliver mRNA products for local and export markets, while also championing a quality culture and contributing to the site's technical leadership.
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.,Monitor key performance indicators to identify and improve inefficiencies.,Support operational metrics, departmental budgets, and site planning.,Investigate complex manufacturing issues with cross-functional teams.,Act as technical expert for audits and inspections.,Collaborate with global sites on data sharing and best practices.,Integrate Lean and Six Sigma principles for continuous improvement.,Execute technical support for media fills, cleaning verifications, and material qualifications.,Strict adherence to Good Documentation Practices and Data Integrity.,Complete training per assigned learning plans and requalification schedules.,Maintain deep expertise in quality systems, cGMP, and industry standards.,Perform additional duties as assigned, including exploring opportunities for integration of Generative AI tools to streamline validation and investigation processes.
Ideal Candidate
Education: Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.,Experience: A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on sterile manufacturing operations.,Demonstrated ability to analyze complex issues and situations.,Experience in a pharmaceutical manufacturing environment, preferably in a role related to aseptic fill finish process, process optimization, or technical support.,Experience with creating and delivering training programs.,Familiarity with process validation principles and statistical analysis techniques.,Technical writing skills and proficiency in investigations and root cause analysis.,Strong communication and presentation skills.,Proficiency in English required.
Minimum Education
Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
Hard Skills
Soft Skills
Work Hours
Full-time
Benefits
Special Commitments
Site-based, requiring full-time presence at Moderna's site.,Embraces a 70/30 work model (70% in-office).
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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