The RoleModerna is on the lookout for a dedicated, dynamic Sr. Manager to join our Analytical Science & Technology team at our state-of-the-art Norwood, MA facility. This role is pivotal for someone who thrives in a fast-paced environment, capable of handling quick-turnaround investigations or projects, especially within our INT program. We're seeking a leader with a robust background in QC investigations and a deep understanding of various analytical methods. If you're a dependable individual who excels in problem-solving, enjoys interdisciplinary collaboration, and can manage multiple projects with precision, we want to hear from you.Here's What You'll DoLead with Excellence:Spearhead our Analytical Science & Technology team, promoting a culture of effective collaboration and communication both within your team and across departments such as QC, Manufacturing, MS&T, and Analytical and Process Development.INT Program Focus:Direct and refine investigations related to analytical release methods with a primary focus on the INT program, aiming to optimize and validate a spectrum of analytical techniques crucial for product characterization, quality control, and stability assessments.Global Investigations Support:Partner with external Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs) to support deviation and out-of-specification (OOX) investigations on a global scale.Technical Documentation:Take charge of authoring, reviewing, and approving key technical documents, including material qualification and validation protocols, summary analysis reports, and certificates of analysis.Method Optimization:Champion efforts in troubleshooting, remediating, changing, and optimizing analytical test methods.Lifecycle Management:Keep a vigilant eye on program lifecycle timelines, ensuring effective communication and timely completion of milestones.Technical Assessments:Conduct in-depth technical assessments of deviations and investigations, bolstering our analytical strategy.Compliance Audit Support:Provide expert guidance during compliance audits, ensuring adherence to regulatory standards.Flexibility and Adaptability:Be prepared to take on additional duties as needed, demonstrating your ability to adapt and lead in a constantly evolving environment.Additional duties as may be assigned from time to timeHere's What You'll Need (Minimum Qualifications)Bachelor's degree in a relevant scientific discipline with at least 12 years of industry experience in a cGMP laboratory setting focused on analytical chemistry and/or bioassays (or MS with 10 years).Proficiency in investigation tools such as Lean Six Sigma, 5 Whys, etc.A thorough understanding of FDA, EU, ICH guidelines and regulations.Demonstrated expertise in method qualifications/validations and familiarity with microbiological sterility pharmacopeia methods.Exceptional troubleshooting skills and the ability to convey complex issues in an understandable manner.Proven ability to prioritize, manage, and complete multiple projects and tasks efficiently and independently.Strong collaboration skills in a dynamic, cross-functional matrix environment.Excellent communication skills, both verbal and written.Here's What You'll Bring to the Table (Preferred Qualifications)Demonstrated experience in quick-turnaround investigations and projectsExtensive experience in QC investigations across a diverse range of analytical methods.Leadership qualities that inspire teamwork, confidence, and innovation.A desire to make an impact as part of a high-growth, transformational company that isBold, 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-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 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 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 ****** . (EEO/AAP Employer) #LI-KP1-
