Role Summary
Associate Director, Analytical Science & Technology (AS&T) – Chemistry & Raw Materials based at Moderna’s Norwood, MA site. Provides scientific, strategic, operational and people leadership. Leads a global team responsible for method validation and transfer strategies of chemistry and raw material commercial methods, implementation, and network data oversight. Partners cross-functionally with Quality Control, Manufacturing, Technical Development, and external partners to drive readiness, consistency, and excellence in analytical sciences.
Responsibilities
- Lead, mentor, and develop a global team of scientists and specialists, fostering technical excellence, accountability, and growth.
- Build a culture of collaboration, innovation, and continuous improvement across internal and external laboratories.
- Ensure team priorities are clear, aligned to business objectives, and executed with a focus on compliance, quality, and scientific rigor.
- Lead the design of method validation and transfer strategies for raw material and chemistry methods.
- Provide scientific oversight to ensure robustness, reproducibility, and regulatory alignment of methods across the global network.
- Partner with cross functional teams to design and implement a comprehensive raw material qualification strategy, ensuring alignment with regulatory expectations, robust supplier oversight, and global network consistency.
- Provide strategic oversight for global analytical performance and ensure alignment across sites and partners.
- Ensure SOPs, method forms, training documents, and supporting records are complete, compliant, and audit-ready.
- Drive documentation and training materials across laboratories to support QC analyst onboarding and ongoing development.
- Partner with QC leaders to design and oversee training strategies that ensure analyst proficiency across raw material and chemistry methods.
- Provide network-wide data oversight to ensure integrity, consistency, and alignment with global requirements.
- Provide expert support in analytical investigations, including method performance issues and raw material testing challenges.
- Collaborate with CMOs and suppliers to ensure technical alignment, timely resolution of issues, and adherence to company standards.
- Act as a key AS&T point of contact for external partners supporting raw materials and chemistry testing.
Qualifications
- Advanced degree (MS/PhD) in Chemistry, Analytical Sciences, Pharmaceutical Sciences, or related field; BS with extensive experience may be considered.
- 10+ years of relevant experience in pharmaceutical/biotechnology analytical sciences, with direct experience in raw materials and chemistry-focused methods.
- Strong expertise in method validation, transfer, lifecycle management, and global regulatory expectations (ICH, USP, Ph. Eur., etc.).
- Proven experience leading, mentoring, and developing scientific teams in a global, matrixed environment.
- Strong collaboration and influencing skills, with the ability to drive alignment across internal stakeholders, global QC, and external partners.
- Experience supporting QC laboratories, training, and investigations in GMP-regulated environments.
- Strong communication, organizational, and leadership skills with ability to manage multiple priorities in a fast-paced environment.
Skills
- Analytical science leadership
- Method validation and transfer
- Regulatory compliance (ICH, USP, Ph. Eur.)
- Cross-functional collaboration
- Data integrity and network oversight
- GMP environment experience
Education
- Advanced degree in Chemistry, Analytical Sciences, Pharmaceutical Sciences, or related field (MS/PhD preferred).
Additional Requirements
- Occasional travel for site visits, training, or CMO support.