- Lead MS&T teams supporting cGMP drug substance manufacturing of Modernas late-stage clinical and commercial mRNA products, as well as select critical starting raw materials and starting materials
- Lead MS&T teams providing technical support for process monitoring, on-floor support, change control, deviation investigations, and CA/PA for all DS workcenters DNA, chemistry, small-scale clinical DS production, and large-scale clinical/commercial DS production
- Lead MS&T teams providing centralized investigation and CA/PA leadership support on behalf of the internal manufacturing organization
- Lead technical product stewards responsible for managing the site-based new product introduction and process qualification strategies across all technologies and scales, across the program lifecycle
- Author, review, or otherwise contribute to clinical and commercial regulatory filings and health authority question responses. Support inspection readiness and response activities.
- Develop MS&T strategy, plan resource needs and hire and manage employees to meet organizational needs for the present and future.
- Communicate with executive leadership to drive alignment of critical decisions, strategy, and risk mitigations.
- Collaborate extensively with Manufacturing, Quality, Digital, Technical Development, Supply Chain and others to ensure operational excellence in making product.
- Obsessively focus on decreasing variability in the manufacturing environment through practical application of data and operational.
- Collaborate with multiple functions to ensure the manufacturing site maintains a high state of compliance through continued improvements in raw material control, control of microbial contamination, control of consumables quality, control of cleaning, and control of equipment performance. Monitor and improve these critical manufacturing areas through continuous monitoring, data analytics, and collaboration with QA, QC, and Facilities & Engineering. Heres What Youll Bring to the Table:
- Biochemical engineer, chemical engineer, or biological/chemistry science degree with >12+ years of experience in the pharmaceutical or biotechnology industry. Advanced degree preferred (MS, Ph.D.)
- Prior leadership experience managing MS&T, Process Development, or Technical Development groups or function for a pharmaceutical or biotechnology company. Demonstrated ability to mentor and develop a technical staff.
- Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).
- Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development. 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, 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. 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 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 contact the Accommodations team at (EEO/AAP Employer)
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Director, Manufacturing Sciences and Technology - Norwood, United States - Moderna, Inc.
Description
The Role:
This position is part of Modernas Manufacturing Sciences and Technology (MST) team responsible for ensuring robust production of Drug Substance (DS) using our mRNA manufacturing platform at our Norwood site. The Director/Senior Director will have full responsibility for both clinical and commercial GMP manufacturing support and be an integral member of the internal manufacturing leadership team.
Heres What Youll Do:
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