Senior Pharmaceutical Manufacturing Specialist

This is an exciting opportunity to join our team as a Principal Research Associate MS&T Drug Product. As a key member of our team, you will be responsible for establishing drug product (DP) MS&T activities at our Clayton, Australia site. You will report to the MS&T Drug Product Site Lead and 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.

Your expertise will drive the development of compliant, high-quality systems and processes critical to delivering mRNA products for local and export markets. As a senior team member, you will champion quality culture and contribute to the site's technical leadership.

Your 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.

Your Responsibilities Will Also Include:

• Strict adherence to Good Documentation Practices and Data Integrity.
• Completing training per assigned learning plans and requalification schedules.
• Maintaining deep expertise in quality systems, cGMP, and industry standards.
• Performing additional duties as assigned, including exploring opportunities for integration of Generative AI tools to streamline validation and investigation processes.

Moderna Mindsets:

• We behave like owners. The solutions we're building go beyond any job description.
• We digitize everywhere possible using the power of code to maximize our impact on patients.

Required Skills and Qualifications:

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.

This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.

As part of Moderna's commitment to workplace health and safety, this role may be subject to pre-employment and periodic medical assessments, in line with relevant legal and operational requirements.

PREFERRED QUALIFICATIONS:

• 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.

Benefits:

We believe that when you feel your best, you can do your best work. That's why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• 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 investments
• Location-specific perks and extras

About Us:

We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.