Manufacturing Supervisor, Drug Substance

vor 2 Monaten

Melbourne, Österreich Moderna Therapeutics Vollzeit

Manufacturing Supervisor, Drug Substance - Day Shift
Location: Melbourne - Australia
Time Type: Full time
Posted on: Posted Today
*We are excited to announce that we are expanding our team and have multiple positions available for this role - join us in shaping the future*
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 is seeking a Day Shift Manufacturing Supervisor, Drug Substance for our state-of-the-art mRNA vaccines production unit at our Resilience Site in Australia. This role is pivotal in managing production timelines, ensuring cGMP compliance, and overseeing health and safety regulations. You will be instrumental in the technical ramp-up of manufacturing processes and be required to demonstrate digital proficiency and operational leadership.
Here's What You'll Do:
Within 3 Months, You Will…

Enforce safety procedures and Moderna's guidelines, ensuring compliance with local HSE requirements.
Start fostering a collaborative relationship with the Night Shift team.
Develop batch records, SOPs, and training materials for various phases of commercial programs.
Coordinate with the Quality Assurance team for the timely disposition of commercial batches.
Manage documentation processes and oversee training and development of staff.

Within 6 Months, You Will…

Establish robust processes for Batch Disposition.
Manage team performance and development, including regular one-on-one sessions.
Collaborate with Supply Chain to maintain inventory and review process orders.
Respond to routine equipment, process, and digital issues, ensuring continuous operation.

Within 12 Months, You Will:

Lead projects aimed at continuous improvement, aligning operations with corporate goals and commercial demand.
Drive initiatives to maintain manufacturing excellence.
Ensure team performance monitoring and make necessary adjustments for improvement.
Lead in troubleshooting and optimizing manufacturing processes.

Here's What You'll Bring to the Table:

Typically, 5-7+ years of experience in a GMP manufacturing environment.
A Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field preferred.
Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP.
Demonstrated commitment to Moderna's values of Bold, Collaborative, Curious, and Relentless, embodying these values in the workplace.
Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required.
Exceptional written, oral communication, and organizational skills required.
Skills in project management, including planning, execution, monitoring, and closing projects.
Experience with chromatography and tangential flow filtration would be an asset.
Experience in audit / inspection preparation, understanding Health authority and regulatory guidelines.
Knowledge of environmental monitoring practices in a cleanroom or controlled manufacturing environment.
Specific expertise in mRNA technology, vaccine production and equipment - beyond a general scientific understanding.
Understanding/Detailed knowledge of regulatory requirements specific to mRNA drug products and vaccine production.
Expertise in quality control measures and assurance processes specific to pharmaceutical manufacturing.
Knowledge of validation processes for manufacturing equipment and processes.
Ability to analyze production data and generate reports for management.
Specific methodologies for continuous improvement, such as Lean, Six Sigma, or others.
Experience in leading Kaizen events or other process optimization initiatives.
Experience in coordinating with supply chain for raw materials and inventory management.

About Moderna:
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity 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.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
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