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Senior Specialist, Analytical Technical Operations

$89.9k - $143.8k
Full-time

Moderna

The Role The Individual is responsible for enabling efficient analytical execution across CMC Development programs through strategic planning, stability study management, and digital operations support. This role serves as a key operational partner, translating inputs from multiple laboratory and business systems into executable testing plans while ensuring analytical activities are aligned with program priorities, timelines, and development objectives. Working across Analytical Development, Process Development, and other CMC functions, the Candidate drives operational excellence through process optimization, automation, and digital integration initiatives. The role combines scientific understanding, project coordination, and data-driven decision-making to support stability programs, accelerate development timelines, and deliver high-quality analytical data that informs critical product development and regulatory decisions. What You'll Do Develop and maintain integrated analytical testing schedules by consolidating inputs from multiple digital systems, program priorities, and laboratory capacity to support CMC Development activities. Author, review, and manage stability protocols and studies for novel mRNA and Lipid Nanoparticle (LNP) drug candidates, supporting shelf-life determination, IND-enabling studies, and product development milestones. Generate, review, trend, and interpret analytical data; perform peer data review; prepare technical summaries and data packages; and communicate results and recommendations to stakeholders across CMC Development. Manage multiple program timelines simultaneously, ensuring testing milestones, study deliverables, and reporting commitments are completed on schedule. Collaborate with cross-functional partners to support forecasting activities, stage-appropriate testing strategies, sample management, and development program planning. Design and implement digital tools, automated workflows, and operational processes that improve efficiency, enhance throughput, and support scalable analytical operations. Lead efforts to integrate new digital capabilities and improve connectivity between laboratory and enterprise systems, enabling more effective planning and execution. Maintain accurate and compliant documentation while partnering with analytical scientists and technical teams to support method understanding and successful execution of analytical activities. Here’s What You’ll Need (Basic Qualifications) Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline. 6-8 years of experience in biotechnology, pharmaceuticals, analytical development, technical operations, or CMC Development. Experience managing stability studies, analytical testing programs, or laboratory operations within a regulated environment. Experience working with LabVantage, Benchling, or similar laboratory information management (LIMS), electronic laboratory notebook (ELN), and data management systems. Strong project management, organizational, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment. Excellent written and verbal communication skills with experience presenting technical data to diverse stakeholders. Here’s What You’ll Bring to the Table (Preferred Qualifications) Experience supporting mRNA, LNP, biologics, or other advanced therapeutic modalities. Knowledge of CMC Development, stability programs, and regulatory requirements supporting IND submissions and product development. Experience with process automation, workflow optimization, data visualization, or digital transformation initiatives. Demonstrated ability to analyze, trend, and interpret analytical data to support scientific and operational decision-making. Experience leading or supporting cross-functional programs and projects, including planning, prioritization, stakeholder management, risk mitigation, and execution against key milestones. Key Competencies Analytical Operations & Planning Stability Study Management Digital Systems & Automation Cross-Functional Collaboration Project & Program Management Data Analysis & Technical Reporting Continuous Improvement Scientific Problem Solving Technical Communication Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future Location-specific perks and extras The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since 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. 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. Our Working Model 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. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 View email address on click.appcast.io. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-KH1 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling View phone number on click.appcast.io or emailing View email address on click.appcast.io if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Vacancy posted 2 days ago
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