The Specialist on Moderna's Drug Product team is key to ensuring the production of high-quality mRNA-based medicines. Utilizing their knowledge of manufacturing practices, bioprocess unit operations, process engineering, and digital systems, they will provide essential technical guidance. This role involves supporting the startup of the Formulation, Fill & Finish processes and transitioning to a cGMP-qualified operational facility. The Specialist will develop operational procedures, train manufacturing staff, support technology transfer efforts, contribute to problem-solving and improvement initiatives, and lead projects focused on achieving efficient, Right-First-Time outcomes.
Here's What You'll Do
Adhere to and promote safe work practices, following safety procedures and guidelines.
Provide on-the-floor coaching and/or training for the manufacturing team in process execution, troubleshooting, cGMPs, and safety practices.
Lead tech transfers and serve as the manufacturing lead on various projects.
Lead and participate in cross-functional teams to drive changes, improvements, and resolve complex manufacturing operation issues.
Develop batch records, SOPs, and training materials in collaboration with process SMEs.
Partner closely with QA to ensure rapid disposition of batches, including timely reviews of batch records, protocols, and supporting deviation investigations.
Manage CAPA implementation and own the resolution process for manufacturing deviations.
Manage change controls and oversee the introduction of simple equipment/tools.
Prepare operations for new product introductions, technology transfers, and major capital projects.
Participate in equipment startup, commissioning, and validation activities.
Engage in forums for continuous improvement, gathering requirements, and prioritizing issues.
Support both internal and external audits to ensure regulatory compliance.
Maintain a flexible work schedule to meet production and project demands.
Escalate issues potentially impacting business objectives.
Here's What You'll Need ( Basic Qualifications)
Education: BS in a relevant science or engineering discipline.
Experience: 2-3 years in biopharmaceutical operations, with substantial involvement in cGMP environments.
Specific Certifications or Training: Not specified, but training in cGMP practices and familiarity with electronic batch records and 21 CFR part 11 requirements is crucial.
Other Quantifiable Preference: Demonstrated ability to work independently with minimal supervision, excellent problem-solving skills, and effective communication and leadership in cross-functional settings.
This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.
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)
