Job Description:
As a Principal Research Associate, MS&T - Validation at Moderna Therapeutics, you will play a pivotal role in establishing the foundational validation and MS&T operations at our Clayton, Australia site (MTC-M). Reporting to the MS&T Drug Product Site Lead, you will serve as a technical specialist ensuring robust validation practices, technology transfers, continued process verifications, investigations, and change management in support of a new drug product manufacturing line.
Key Responsibilities:
* 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.
Requirements:
* Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
* 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.