Drug Substance Business Standards Lead
ModernaTX, Inc.

Job Info

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The Role:

The Drug Substance Business Standards Lead is responsible for driving standardization of business processes and systems across the Global Drug Substance Network, with an emphasis on simple, robust solutions that fit the organization's broad mission. This role involves leading cross-site and occasionally cross-network teams for development and deployment of improved, standard processes across all applicable sites and teams. This role serves as a key strategic integrator for across the network, and will partner with functionally and geographically diverse groups to deliver results.

Here's What You'll Do:

• Collaborate with the Global DS Lead Team and SMEs throughout the organization to identify improvement opportunities, prioritize, and align resources to drive standard development and implementation across the organization.
  
• Ensure any improvements are implemented across all DS Manufacturing Sites, driving towards a common set of operational standards and business practices over time.
  
• Set clear goals, objectives, and expectations for project/initiative team members and monitor execution. Establish governance approach to ensure progress and alignment over-time for the portfolio of standards being developed / implemented.
  
• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
  
• Follow all relevant GMP and GLP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
  
• Follow 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.
  
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
  

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

• Education: Bachelor's degree in STEM or relevant field. Master's degree preferred.
  
• Experience: Minimum of 12 years supporting manufacturing operations in a regulated environment. Working experience in a network setting and across diverse geographies is preferred.
  
• Specific Certifications or Training: Lean Six Sigma Green Belt or Black Belt certification preferred.
  
• Other Quantifiable Preference:
  
  • Proven leadership experience, strong communication skills, and a track record of successful process improvement projects.
    
  • Demonstrated strong understanding of GMP regulations and current industry practices.
    

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.

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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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