Senior Manager, MSAT
Listed on 2026-01-12
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Engineering
Process Engineer, Manufacturing Engineer, Quality Engineering, Systems Engineer
Senior Manager, MSAT (Bio Space)
OverviewJoining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. In this highly impactful role you will serve as a central figure in ensuring the successful transfer and validation of mRNA-based drug product manufacturing processes. Based at our Norwood site, you will lead the execution of Technical Transfer and Process Validation activities, including protocol creation, PPQ execution at internal and external facilities, and report generation.
You will act as the driving force for cross‑functional collaboration across technical and quality teams to deliver on operational readiness, regulatory alignment, and manufacturing excellence. Your work will support the global expansion of Moderna’s manufacturing network and provide close exposure to cutting‑edge digital and AI‑based tools as part of our broader digitization efforts.
- Ensure the successful technology transfer and process validation of Moderna processes at both internal and external drug product manufacturing sites.
- Lead cross‑functional project teams for new product introductions and continuous process improvement efforts.
- Develop and maintain comprehensive documentation packages to support process validation and technical transfer.
- Be the primary technical contact for validation‑related investigations, including root cause analysis and corrective action planning.
- Create and manage change controls related to new product introductions in alignment with Moderna’s Quality Systems.
- Drive alignment with other Moderna manufacturing sites through knowledge sharing, data exchange, and harmonized solutions.
- Support regulatory submissions and respond to queries from health authorities related to process validation.
- Represent the MSAT function during regulatory audits, ensuring inspection readiness and compliance.
- Implement industry best practices and continuous improvement methodologies in technical transfer and validation activities.
- Facilitate risk assessments and mitigation strategies across stakeholders to ensure smooth project execution.
- Promote a culture of safety, collaboration, and innovation in all aspects of work.
- We behave like owners, taking full accountability for cross‑functional deliverables and driving complex tech transfer initiatives from planning through execution.
- We digitize everywhere possible, using code and data to maximize our impact on patients, integrating digital tools, data‑driven decision‑making, and emerging technologies such as AI.
- Education: Science degree with pharmaceutical/biotechnology applicability (pharmacy, chemistry, biotechnology, engineering, etc).
- Experience:
- Minimum of 10 years in the pharmaceutical/biotechnology industry.
- Experience with cGMP manufacturing, drug product technical transfer, and process validation.
- Knowledge of drug product manufacturing including formulation, sterile filtration, aseptic processing, visual inspection, labeling, and packaging.
- Language: Strong proficiency in English.
The salary range for this role is $ – $.
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.
Benefits include:
- Best‑in‑class healthcare coverage, plus voluntary benefit programs.
- 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 investment opportunities.
- Location‑specific perks and extras.
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.
AccommodationsModerna is committed to offering reasonable accommodations to qualified job applicants with disabilities. For accommodations during the hiring process or to perform essential job functions, contact the Accommodations team at leavesan
Export Control NoticeThis position may involve access to technology or data subject to U.S. export control laws. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible. Moderna is unable to sponsor non‑U.S. persons for an export control license.
Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.
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