The Role:ModernaTX, Inc. seeks a Sr. Manager for its Norwood, Massachusetts location.
Here's What You'll Do:- Coordinate and manage all aspects of Chemistry, Manufacturing & Controls (CMC) activities related to product launch, including planning, execution, andmonitoring of progress.
- Liaise between all CMC functions, ensuring effective communication and alignment of project plans with the needs of the business.
- Identify and implement strategies to ensure timely product launch.
- Partner in the creation and delivery of project plans, and ensure that all activities adhere to regulatory standards.
- Collaborate with cross-functional teams such as Regulatory Affairs, Quality, Manufacturing, and Supply Chain to ensure a smooth product launch.
- Identify potential risks and challenges in the vaccine launch process, and devise mitigation strategies; escalating as necessary.
- Provide regular updates to the core team and senior management on the status of the seasonal launch.
- Foster a culture of continuous improvement, identifying opportunities for process optimization within the CMC functions.
- Plan, drive and deliver the project / program and its activities in accordance with the mission and the goals of the organization.
- Ensure that project / program activities operate within the policies and procedures of the organization.
- Work with individual project lead at each POD to establish plans and goals for each project and ensure harmonization across projects to meet organization need.
- Own project dashboard.
- Ensure completeness and accuracy of all projects and status including KPI tracking and resource management.
- Serve as a drug product team leader for newly developed products.
- Ensure a robust manufacturing process taking into consideration COGM.
- Author appropriate Drug Product CMC sections for global regulatory submissions for new products as well as life cycle changes.
Here's What You'll Bring to the Table:Minimum requirements:
- A minimum of a Bachelor's degree, or foreign equivalent, in Engineering (any), Pharmaceutical Science, or a related field and 7 years of progressive, post-baccalaureate experience managing projects within the pharmaceutical industry.
- Seven (7) years of experience must include:
- Working within CMC operations including Manufacturing, Science & Technology (MSAT), production, and quality;
- Ensuring compliance with regulatory standards and requirements for launch of new drug products; and
- Working with cross-functional stakeholders.
Apply at (Job ID: R17129) or email resume and cover letter to ...@modernatx.com with subject line: R17129.
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 ModernaSince 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 ...@modernatx.com. (EEO/AAP Employer)