Principal Research Associate Ms&T Dp
Vor 6 Tagen
Job Overview Principal Research Associate MS&T – Validation at Moderna Moderna is a global leader in mRNA technology, building a portfolio of development programs across a range of diseases. The Melbourne office focuses on commercial operations, delivering innovative products to the Australian market. This role is based at the Clayton, Australia site (MTC‑M) and will establish Drug Product (DP) MS&T activities for a new 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 and author/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. Maintain adherence to Good Documentation Practices and Data Integrity. Complete training per assigned learning plans and requalification schedules. Explore opportunities for integration of Generative AI tools to streamline validation and investigation processes. Champion a quality culture and contribute to the site's technical leadership. Basic Qualifications Education: Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field. Experience: Minimum 3–5 years in the biotech or pharmaceutical industry, focusing on sterile manufacturing operations. Location: Required to be on site full‑time (no remote work). Preferred Qualifications Experience in a pharmaceutical manufacturing environment, preferably in aseptic fill‑finish, process optimization, or technical support roles. Experience 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. Benefits Quality healthcare and insurance benefits. Lifestyle Spending Accounts. Free premium access to fitness, nutrition, and mindfulness classes. Family planning and adoption benefits. Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown. Savings and investment options. Location‑specific perks and extras. Equal Opportunity Employer Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Moderna offers reasonable accommodation or adjustments to qualified job applicants with disabilities in accordance with applicable laws. #J-18808-Ljbffr
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Melbourne, Österreich Moderna VollzeitPrincipal Research Associate MS&T DP - Validation Join to apply for the Principal Research Associate MS&T DP - Validation role at Moderna Principal Research Associate MS&T DP - Validation 2 weeks ago Be among the first 25 applicants Join to apply for the Principal Research Associate MS&T DP - Validation role at Moderna Get AI-powered advice on this job and...
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