Sr. Specialist, Manufacturing
ModernaTX, Inc.

Job Info

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The Role

In this role, you will be part of a cohesive team responsible for producing high quality mRNA-based medicines for production specializing in Moderna's Individualized Neoantigen Therapy. The Manufacturing Sr. Specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to support projects as well as day to day operations through deviation and CAPA writing with a focus on but not limited to DNA, mRNA, or Fill Finish Operations. The Sr. Specialist will be a key player during Marlborough operational readiness efforts by supporting startup activities, investigating issues that arise, and driving projects within the team focused on delivering results in an efficient manner. This position will be M-F, with occasional tasks outside of working hours to support 24/7 operations.

Here's What You'll Do

• Practice and promote safe work habits and adheres to safety procedures and guidelines
  
• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events
  
• Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)
  
• Conduct document revisions and/or document management including batch production records and manufacturing procedures
  
• Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues
  
• Follow-up on requests, issues, and projects and report statuses to manager/ working teams
  
• May perform metric trending
  
• Generate technical protocols and reports
  
• Support internal and external audits
  
• Work independently with minimal supervision and direction
  
• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion
  

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

• Bachelor's Degree with 8-10 years of experience in biopharmaceutical operations or a Master's Degree with 5+ years industry experience; Degree in Engineering or Life Sciences is preferred
  

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

• Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique), drug product operations or a similar complex specialized environment
  
• A comprehensive understanding of investigational techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe
  
• A comprehensive understanding of regulatory requirements and their applications in a cGMP environment
  
• Minimum of 2 years' experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment
  
• Excellent written and oral English language skills
  
• Demonstrated ability to lead cross functional teams and deliver results with minimal supervision
  
• Ability to manage multiple competing priorities in a fast-paced environment
  
• Experience working with electronic batch records and thorough understanding of 21 CFR part 11 requirements
  
• Background in lean manufacturing methodologies and operational excellence
  
• Experience interacting with representatives of regulatory agencies
  
• Project management experience
  
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
  

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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