- Lead the end-to-end product lifecycle management of custom/critical raw materials, including specification development, supplier selection, and qualification while ensuring alignment with regulatory guidelines and industry standards.
- Collaborate with cross-functional teams, including Process Chemistry, Analytical Development, Quality Assurance, Operations, Regulatory Affairs and Process Development to develop product requirements and align specifications with program needs.
- Coordinate cross functional technical investigations and problem-solving activities for critical raw materials used across multiple commercial, clinical, and development programs.
- Ensure alignment between CMC long range plan demand and supply planner projections.
- Stay current with industry trends and regulatory requirements related to raw materials, providing guidance and recommendations to internal stakeholders.
- Lead a cross-functional team of scientists and engineers, providing mentorship, guidance, and performance feedback to foster a high-performing and collaborative work environment.
- Act as an integrator to connect technical SMEs with operational, quality, and drug product lifecycle teams, providing technical support and guidance to internal and external stakeholders.
- Additional duties as may be assigned from time to time. Heres What Youll Need (Minimum Qualifications)
- BS. in a scientific discipline (Chemistry, Biochemistry, Chemical Engineering, or related field) with a minimum of 8 years or MS with a minimum of 6 years of relevant experience in the biopharmaceutical industry. Heres What Youll Bring to the Table (Preferred Qualifications)
- Experience in the qualification and CMC lifecycle of custom raw materials, including the development of specifications, supplier selection, and ongoing performance monitoring.
- Experience with custom lipid, enzyme, plasmid, and/or nucleotide manufacturing is desirable.
- Familiarity with current Good Manufacturing Practices (cGMP) and regulatory requirements for raw materials in the biopharmaceutical industry.
- Proven track record of successfully leading cross-functional teams and strong project or program management experience.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
- Strong problem-solving and risk-based decision-making abilities, with a strategic mindset and attention to detail.
- Ability to work in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, 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, 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, Technical Development, Raw Materials - Norwood, United States - Moderna, Inc.
Description
The Role
In this role, you will be accountable for defining the CMC lifecycle road map and guiding the raw materials through key lifecycle milestones such as definition of specifications, process and method development, and qualification for custom small molecules. The Senior Manager will lead a cross functional team of scientists and engineers while acting as a single point of contact for all technical support activities and product lifecycle plans. This individual will play a key role in ensuring alignment between key stakeholders within the Technical Development and wider CMC organization while driving activities to ensure the availability, quality, and compliance of raw materials used in the manufacturing of Moderna's mRNA therapeutics and vaccines.
Heres What Youll Do
