Reporting to the Associate Director of Commercial DS MS&T, Moderna is seeking an experienced Engineer or Scientist to join the MST team. This team is responsible for ensuring the robust production of our mRNA platform in Late Stage and Commercial cGMP Manufacturing. The individual will work closely within MST, and with Process Development, Manufacturing, Regulatory, and Quality, to ensure all aspects of technology transfer and technical support are successfully executed and maintained. The role requires a strong background in GMP quality systems, processing equipment and unit operations, and regulatory guidelines for pharmaceutical manufacturing. Strong communication skills are required for effective team leadership and cross-functional coordination.
Heres What Youll Do:
Lead/support global technology transfer from clinical to commercial manufacturing, including facility fit assessment, process and equipment requirement definition, and development of URSs, PFDs, and technology transfer documents
Author documents and support agency filing preparation (BLA, MAA, etc.)
Lead global change controls to support and improve and align commercial manufacturing processes across the Moderna network
Provide technical expertise and guidance to establish robust unit operations
Help ensure operations are in compliance with all Regulatory, EHS, and cGMP quality systems that assure proper design, monitoring, and control of manufacturing processes across the Moderna commercial organization
Troubleshoot process and equipment issues, including resolution of deviations and implementation of CAPAs
Heres What Youll Bring to the Table:
Biochemical engineering, chemical engineering, biochemistry, or related technical discipline. BS with 8+ years of experience or MS with 5+ years of experience in pharmaceutical or biotechnology manufacturing including substantial GMP experience
Experience with process tech transfer, including facility fit assessment and definition of process and equipment requirements
Experience and familiarity with various process operations priorities including sourcing, technical transfer, R&D, process improvement, and troubleshooting
Business acumen including experience with Smartsheet or Microsoft project or equivalent management tool and proven ability to learn and adapt to new systems
Proven ability to effectively lead teams and collaborate with internal and external partners
Solid understanding of practices required to conform to health agency guidelines that control the authorization and licensing of pharmaceutical products (GMP)
Demonstrated excellence in technical writing. Experience with document authoring for health authority filings is preferred
Proven record of calm under pressure and a positive attitude
Outstanding communication skills (verbal and written)
Travel between commercial sites may be required.
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!
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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. Were 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 firstname.lastname@example.org. (EEO/AAP Employer)