- Provide expertise in unit operations and cGMP manufacturing, responsible for technical support, change control, safety observations, manufacturing investigations, and person-in-plant coverage for the manufacturing process.
- Support process training for GMP operations and development of process understanding and expertise.
- Lead/participate in cross functional technical process support and investigation teams.
- Partner with Technical Development, Manufacturing, and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities.
- Lead a team of subject matter experts in plasmid, chemistry, and small-scale drug substance processes.
- Be the subject matter expert for plasmid, chemistry, and small-scale drug substance processes. This includes troubleshooting process and equipment issues.
- Independently provide complex technical support of cGMP manufacturing including authoring of complex technology transfer documents, change controls, manufacturing impact assessments, and study protocols.
- Lead complex analysis and review of data. Proactively identify improvement projects and performance risks. Heres What Youll Bring to the Table:
- Biochemical engineer, Chemical engineer, Biochemistry, Biology, or STEM background. BS with 10+ years of experience or MS with 8+ years experience in a pharmaceutical or biotechnology company.
- Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.
- Demonstrated expertise bioprocessing including purification of protein and/or nucleic acids. Expertise in at least one of the following areas: chromatography, membrane separations, enzymatic reactions, and formulation.
- Technical agility. The capability to manage diverse technical areas.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Preferred: Expertise in molecular biology
- Preferred: Experience in biologics process development and scale up / scale down.
- Preferred: Experience with single use bioprocessing technologies.
- Preferred: Proven track record leading and managing cross functional teams.
- Preferred: Knowledge of digital cGMP tools. For example: SAP, OSI PI(), MES (eBR), Unicorn, eQMS 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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Sr. Manager, Manufacturing Science and Technology - Norwood, United States - Moderna, Inc.
Description
The Role:
The Sr. Manager, MS&T, will be part of Modernas Manufacturing Science and Technology team responsible for process implementation, technical support, and person-in-plant coverage to ensure robust production of our DNA plasmid, chemistry, and small-scale drug substance processes. The individual will lead a team and work collaboratively with cross functional stakeholders such as Technical Development, Manufacturing, Regulatory, and Quality, to ensure all technical aspects of production are successfully executed.
Heres What Youll Do:
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