Senior Specialist, Analytical Technical Operations
Norwood, MN - USA
Job Summary
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 Youll 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.
Heres What Youll Need (Basic Qualifications)
- Bachelors 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.
Heres What Youll 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. Thats why our benefits and well-being resources are designed to support youat 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 $89900.00 - $143800.00. 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 individuals 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 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 persons 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 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
Were 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 .
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 applicants 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.-
Required Experience:
Senior IC
About Company
Learn how we’re changing the world of medicine. Discover career opportunities, our product pipeline, and browse media resources. Meet Moderna.