Manufacturing Supervisor, Clinical & Commercial Drug Substance
ModernaTX, Inc.

Job Info

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The Role:

Clinical & Commercial Drug Substance Operations is responsible for the execution of processing and combining mRNA and LMX/LNP for clinical pipeline products as well as commercial seasonal vaccines in a GMP regulated environment. A Manufacturing Supervisor oversees a team responsible for the execution of applicable manufacturing unit operations, following relevant standard operating procedures and cGMP regulations. The work is conducted within a clean-room environment and typically involves limited physical activity, lifting and standing for periods of time.

Here's What You'll Do:

• Practice and reinforce safe work habits and adhere to Moderna's safety procedures and guidelines.

• Follow and promote all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• Ensure tasks are executed precisely utilizing the reader-doer human performance tool in area of responsibility as defined in internal guiding documents including, but not limited to standard operating procedures (SOPs) and work instructions and spending no less than 50% of time on the floor with team.

• Follow and promote Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

• Working in grade C environments and ensuring the manufacturing area is clean and remains in a state of control.

• Adhere to and promote documented waste handling procedures and respect environmental regulations.

• Complete and drive completion of training in assigned required learning plan for self and team according to the defined timing and the prescribed requalification cadence of gowning and vision if applicable.

• Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS

• As a Qualified Trainer (QT), perform On the Job Trainings (OJTs) to accelerate the assimilation and training of colleagues on unit operations and supporting business processes.

• Understands physical and digital systems governing equipment and processes to enable complex troubleshooting and assists investigations as required.

• Oversee aseptic processing of mRNA and LMX/LNP to formulate clinical & commercial drug substance using Moderna specific technologies involving chromatography, multiple filtration methods and nano-mixing operations.

• Oversee filling and dispensing activities to final container closure for finished clinical and commercial drug substance prior to forward processing.

• Perform Electronic Batch Record reviews (eBRs) as required.

• Appropriately respond to process alarms based on criticality and function.

• Responsible for audit readiness of their assigned area and equipment.

• As an owner within Clinical Drug Substance, initiate and partner with Quality to resolve deviations.

• Set clear goals, objectives, and expectations for team members and monitor execution.

• Provide coaching, guidance and direction to employees in alignment with organizational strategies and priorities spending no less than 50% of time on the floor with team.

• Inspire and motivate team members to achieve their full potential.

• Establish succession plan(s) and employee development plans to support them.

• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.

• Identify and assign appropriate delegates to support business in times of absence. Approval authority for process changes within area of responsibility. Approval can be delegated from the Manufacturing (Work-center) Manager/Sr. Manager/Associate Director to Supervisor, Manufacturing as required.

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

• Education/Experience: Bachelor's Degree with 3-5 years' industry experience.

• Specific Certifications or Training: None

• Other Quantifiable Preference: Prior team and/or project leadership experience. Strong understanding of GMP regulations.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

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 proud to be an equal opportunity workplace and is an affirmative action employer.

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. Moderna is an E-Verify Employer in the United States. 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 to qualified job applicants with disabilities. Any applicant requiring an accommodation 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 team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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