Production Manager

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 presence in Tokyo, a city known for its blend of tradition and innovation. Our new commercial office here will focus on bringing our advanced mRNA products to the Japanese market. Nestled in the heart of Tokyo's vibrant landscape, we're looking to integrate into the local biotech scene while contributing our global expertise. We welcome professionals who are passionate about making a difference in healthcare to join our team. Here you'll be part of a community dedicated to simple yet profound goals: enhancing health outcomes and providing cutting-edge treatments in Japan. Join us in Tokyo where your efforts will help shape the future of medicine in an environment that values both tradition and innovation.

In this role, you will lead a cohesive team responsible for enzyme production that complies with quality standards. The enzymes are used as materials for the production of template DNA (meDNA), which is a starting material for drug substances used in pre-clinical and clinical settings. This position is located at Shinkiba, Tokyo. You will be a hands-on front-line leader, accountable for leading a team in support of both stakeholders and High Throughput Operations and drug substance production to deliver enzymes for the production of meDNA. Applying existing knowledge of bioprocess unit operations and operational excellence while learning new processes and the Moderna Enzymatics platform, you will enable technical and operational success while keeping employee safety and product quality at the forefront. You will manage a high-performing, flexible operations team capable of meeting constantly evolving Moderna stakeholders' timelines and priorities. Additionally, you will provide input to senior management on resource, training, or other needs to ensure business and financial goals are met.

Here’s What You’ll Do

• Ensure safe and high-quality production of enzymes
• Establish and maintain a safety, quality, and continuous improvement culture driven team
• Oversee the hiring, training, development, retention, and performance of staff for execution
• Provide on-the-floor coaching of the operations team in execution of the process, troubleshooting, and safety practices
• Identify risks and escalate communicate issues that could impact metrics and process performance
• Work with process SMEs to develop SOPs and training materials and ensure appropriate training of staff and adherence to established procedures and operational excellence practices
• Own and drive good shift handover practices (in partnership with the supervisors on either side of your schedule)
• Adhere to laboratory gowning procedures
• Adhere to documented waste handling procedures to respect environmental regulations
• Exercise independent judgement and decision-making as appropriate
• Development of effective working relationships with stakeholders at Norwood and cross-functional partners
• Support and/or lead continuous improvement projects, goals, and/or OKRs
• Additional duties as may be assigned from time to time

The key Moderna Mindsets you’ll need to succeed in the role:

• We pursue options in parallel: Managing multiple projects and priorities simultaneously is crucial for success.
• We prioritize the platform: Ensuring that enzyme production aligns with Moderna's broader mission and platform goals.

Here’s What You’ll Need ( Basic Qualifications)

• At least 9 years of experience in experimental research or manufacturing in related fields.
• At least 5 years of project management experience in manufacturing in related fields.

Languages

• Japanese Language Proficiency Test N1 or higher
• English proficiency: Advanced communication skills to negotiate and coordinate all manufacturing-related tasks with the U.S. headquarters.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Strong leadership and communication skills to lead a team with diverse backgrounds and work together while enhancing motivation.
• Ample knowledge of manufacturing planning, processes and quality management, with experience in creating related documents (experience in a GMP environment is desirable). Particularly, knowledge of concepts such as 6S and Lean Manufacturing, Six Sigma, and documentation methods necessary for manufacturing practices such as batch record procedures is desirable.
• Ability to flexibly respond to a dynamic work environment and find solutions.
• Ability to cooperate, listen well, and actively discuss team challenges and solutions.
• Exceptional analytical and communication skills (oral and written)
• Subject Matter Expert on the production of enzymes or proteins is preferred
• Experience with cell culture / fermentation / purification operations
• Excellent communication and presentation skills
• Strong leadership, collaboration, and team building skills
• Skill in conflict resolution and crucial conversations (within the team and between functions)
• Fluency in digital systems such as MS Teams, Smartsheet, Excel, etc.
• Proven ability to assess risk and collaborate with support groups to develop suitable action plans and minimize potential impact

Scientific Knowledge (Desirable)

• General understanding of handling E. coli, E. coli culture methods, and protein expression technology.
• General understanding of asceptic manufacturing operations
• General understanding of FPLC operation methods, method creation, and column selection, preparation, and handling.
• Experience in expressing and purifying recombinant proteins using E. coli with various types and methods.
• Experience in asceptic mixing and filling techniques.
• Knowledge and experience in general molecular biological techniques.
• Knowledge of container closure systems.
• Knowledge and handling experience of general chemical reagents.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• 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, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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.

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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

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. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

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.

Moderna is committed to offering reasonable accommodations or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should

contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.

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