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Senior Technical Specialist
2 weeks ago
Senior Technical Specialist - Manufacturing Science & Technology (MS&T)
Join our pioneering team in revolutionizing medicine through mRNA technology. We are seeking a highly skilled Senior Technical Specialist to lead the establishment of MS&T operations at our site.
As a key member of our team, you will be responsible for ensuring robust validation practices, technology transfers, continued process verifications, investigations, and change management in support of a new drug product manufacturing line.
Key Responsibilities:
- Lead formulation, fill/finish, visual inspection, packaging, and related process validation and tech transfer activities.
- Ensure manufacturing alignment with mRNA/LNP platform standards, author and review cGMP documentation.
- Perform risk assessments, generate SOPs, and establish training programs.
- Monitor key performance indicators to identify and improve inefficiencies.
- Support operational metrics, departmental budgets, and site planning.
- Investigate complex manufacturing issues with cross-functional teams.
- Act as technical expert for audits and inspections.
- Collaborate with global sites on data sharing and best practices.
- Integrate Lean and Six Sigma principles for continuous improvement.
- Execute technical support for media fills, cleaning verifications, and material qualifications.
Requirements:
- Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
- A minimum of 3-5 years of experience in the biotech or pharmaceutical industry, with a focus on sterile manufacturing operations.
- Strong analytical skills, with the ability to analyze complex issues and situations.
- Experience in a pharmaceutical manufacturing environment, preferably in a role related to aseptic fill finish process, process optimization, or technical support.
- Excellent communication and presentation skills.
Benefits:
- Quality healthcare and insurance benefits.
- Lifestyle Spending Accounts to create your own pathway to well-being.
- Free premium access to fitness, nutrition, and mindfulness classes.
- Family planning and adoption benefits.
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
Moderna champions a culture of belonging and building an organization that cares deeply for patients, employees, the environment, and communities. We value diverse experiences, backgrounds, and ideas, creating an environment where every employee can contribute their best.
