Technical Operations

5 months ago

Melbourne, Australia Moderna Full time

The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its footprint in Clayton, Australia, enhancing our global operations and resilience efforts. We are building a state-of-the-art facility dedicated to the development and manufacturing of mRNA vaccines, contributing to pandemic preparedness and response capabilities. We are seeking talented professionals to join us in this exciting journey of transforming medicine and impacting lives worldwide.

**Here’s What You’ll Do**:Your key responsibilities will be**:
Collaborate with Moderna’s global Sterility Assurance network to implement standardized, harmonized, and best practices across the site’s sterile manufacturing operations, low bioburden drug substance processing, aseptic techniques, controlled environments, aseptic training, cleanroom behaviors, cleaning, disinfection, sterilization, microbiological testing, and related areas.

Establish and maintain company contamination control strategies and oversee aseptic practices.

Generate and maintain contamination control strategy (CCS) documents for the Australian Site.

Support sterile manufacturing site operations by providing expertise in aseptic processing and behaviors, training development, equipment, and guidance in sterility assurance.

Lead the design and execution of environmental monitoring programs for the Australian facility.

**Your responsibilities will also include**:
Provide input for the design of bioburden-controlled manufacturing processes and sterile fill/finish and packaging technologies, including container-closure integrity and visual inspection.

Provide Quality oversight for commissioning, qualification, and validation initiatives including complex GMP facilities, equipment, and critical utility projects.

Provide Quality oversight of significant deviations, including root cause analysis records, and change controls.

Review protocols, risk assessments, facility changes, and/or control strategies.

Write, review, and approve GMP documentation (SOPs, Forms, Technical Reports, Validation and Qualification Reports, Specifications, change controls, deviations, EM trend reports, etc.).

Lead and participate in internal audits and health authority inspections.

Ensure compliance with applicable Quality Regulations, Standards, and other regional requirements.

Act as the Sterility Assurance SME with external regulators, company management, in addition to acting as SME for new product introductions and applicable capital projects.

Drive continuous improvement of aseptic techniques and practices to maintain product sterility.

Collaborate cross-functionally to enable Quality Culture and a continuous improvement mindset.

**The key Moderna Mindsets you’ll need to succeed in the role**:
**We act with urgency**: The role demands swift and decisive actions to maintain the highest standards in sterility assurance, ensuring patient safety and product quality.

**We question convention**: Innovation in sterility assurance practices and contamination control strategies is crucial for maintaining leadership in mRNA technology.

**We digitize everywhere possible**: Leveraging digital tools and data analysis to monitor and improve sterility assurance processes will be vital for maintaining compliance and efficiency.

Here’s What You’ll Bring to the Table

Strong knowledge of cGMP regulations, ISO standards, USP and, and other relevant guidance documents.

Experience participating in inspections as a Microbiological Subject Matter Expert (SME) and direct interactions with world-wide Health Authorities with diverse global authority (e.g. FDA, MHRA, EMA, PMDA, ANVISA)

Expertise in design, qualification and control of clean facilities and critical utilities.

Experience in data analysis and statistical evaluation and trending of microbiological data.

Experience with conducting technical/risk assessments of in-house and contract sterilization processes or contract microbiological laboratories (preferred). Expertise in investigations/deviation management including, writing, and evaluating microbiological OOS’s and laboratory investigations and manufacturing investigations.

Prior experience with authoring and reviewing of Quality-owned regulatory filing sections.

Strong knowledge in microbiological analytical method lifecycle (including rapid microbiology methods preferred).

Capability to lead, educate, train, and

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