Specialist, Manufacturing

The Role:

Reporting to the Manufacturing Manager, this individual will join a unified team dedicated to manufacturing top-quality mRNA-based medicines for assessment in human clinical trials. The Manufacturing Specialist will leverage their deep understanding of cGMP regulations and downstream biopharmaceutical production processes to manage documentation that supports batch disposition, investigations, equipment, and enhancement initiatives within manufacturing operations. Standard working hours are from Monday to Friday during the day shift.

Here’s What You’ll Do:

• Uphold and promote safe work habits while adhering to safety procedures and guidelines.

• Use manufacturing process knowledge and investigative skills to identify and resolve manufacturing issues, driving continuous improvement in process operations.

• Involved in cross-functional complex investigations, determine root causes, and implement appropriate corrective and preventive actions.

• Handle document revisions and document management, including batch production records and manufacturing procedures.

• Conduct on-the-floor training with staff as necessary.

• Lead cross-functional continuous improvement teams involving Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology.

• Operate independently with minimal supervision and direction.

• Perform tasks that consistently require independent decision-making and the exercise of independent judgment and discretion.

• Monitor production processes and participate in equipment start-up, commissioning, and validation activities.

• Ensure equipment readiness for operation and assist with troubleshooting in case of equipment failure.

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

• Bachelor's Degree with 3-8 years of experience in biopharmaceutical operations or a Master’s Degree with 2-4 years of industry experience; a degree in Engineering or Life Sciences is preferred.

• Preferred to have a proven track record of success in leading or participating in complex projects within a dynamic pharmaceutical or biotechnology manufacturing environment.

• Recognized Subject Matter Expert (SME) in the setup, operation, and process of aseptic filling lines and labeling activities.

• Proficient in computer use for various business aspects, including executing electronic batch records, viewing procedures, and reviewing and approving documents.

• Comprehensive knowledge and understanding of cGMPs and FDA guidelines in Drug Product is mandatory.

• Embodies Moderna’s core values: Bold, Curious, Relentless, 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.

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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