The Role
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to a commercial enterprise with a diverse clinical portfolio of vaccines and therapeutics, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com .
Moderna is advancing a broad pipeline of mRNA medicines across respiratory vaccines, latent and other vaccines, oncology therapeutics, and rare disease therapeutics. Analytical Development plays a central role in enabling this portfolio by delivering robust analytical strategies, methods, characterization, control strategies, and regulatory-ready data packages across the product lifecycle.
Moderna is seeking a Head of Analytical Development to lead the Analytical Development organization, reporting to the SVP, CMC Development, and serving as a key member of the CMC Development leadership team. This leader will be accountable for the end-to-end analytical strategy, operating model, technical standards, organizational capability, and execution needed to advance Moderna programs from early development through late-stage development, commercialization, and lifecycle management.
The incumbent will serve as the leader for Analytical Development, providing scientific, technical, organizational, and talent leadership across analytical method development, product characterization, analytical control strategy, microbiology, potency and bioassay strategy and development, analytical program leadership, analytical technical transfer, regulatory filings from IND/IMPD through BLA/MAA, and post-approval lifecycle management.
This role requires the ability to set enterprise direction, translate portfolio strategy into phase-appropriate technical priorities, make risk-based scientific and operational decisions, and align cross-functional partners across CMC Product Leadership, Process Development, ATO/AST, QC, Quality, Regulatory CMC, Manufacturing, MS&T, Supply Chain, Program Teams, and external CDMO and testing networks. Success requires building leadership depth across multiple sub-functions, establishing clear governance and decision rights, and ensuring that analytical data, methods, specifications, comparability approaches, and regulatory deliverables are scientifically rigorous, operationally executable, and globally inspection-ready.
The leader will also serve as a visible external scientific and technical voice for Moderna, representing the company in selective conferences, scientific forums, regulatory and industry workshops, and industry consortia to influence analytical practices; benchmark emerging technologies; and bring external insights back into Moderna’s strategy, capability roadmap, governance, and talent development.
Here’s What You’ll Do
Lead the Analytical Development organization as the functional head, setting the overall vision, strategy, priorities, operating model, technical standards, governance, resource agenda, and talent strategy for the function.
Own end-to-end analytical development strategy across the product lifecycle, including early development, pivotal-enabling and late-stage development, PPQ/BLA-enabling activities, commercialization, post-approval changes, and lifecycle management.
Provide strategic and technical leadership across Analytical Development sub-functions, including Analytical Sciences, PhysChem method development, product…