ASU CMC Technical Integration Lead

ModernaTX • Norwood, MA

6d • Onsite

About The Position

The ASU Engine & Global Projects team within Global MS&T is seeking a highly skilled and motivated ASU CMC Technical Integration Lead – COVID/Flu, to drive integrated CMC technical execution for the COVID/Flu Annual Strain Update (ASU). This technical integration role is accountable for connecting Research, Technical Development, MSAT, manufacturing, quality, regulatory, supply, internal site, and CMO inputs into one integrated COVID/Flu ASU technical readiness view, ensuring material readiness, data readiness, evidence readiness, DS-to-DP interface readiness, and site / CMO readiness are technically sound, visible, connected, and decision-ready. The successful candidate will have the technical judgment to review readiness inputs, pressure-test whether data and evidence are adequate to support ASU decisions, challenge gaps or unsupported assumptions, and translate complex CMC information into clear risks, tradeoffs, options, escalation needs, and governance-ready recommendations. While TD and functional owners retain accountability for technical execution, source data, technical rationale, and approved content, this role owns the end-to-end technical integration required to protect filing- and launch-critical ASU commitments and improve execution year over year.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related discipline.
• 8+ years of experience in the biotechnology, pharmaceutical, vaccine, or related industry.

Nice To Haves

• Technical CMC judgment across Research, TD, MSAT, Manufacturing, Quality, Regulatory, Supply, internal sites, and CMOs, with the ability to understand, interpret, and challenge data readiness and evidence sufficiency for ASU decisions.
• Ability to translate strategy and governance direction into integrated technical execution plans with milestones, risks, dependencies, readiness criteria, decisions, owners, and escalation timing.
• Strong DS / DP interface understanding and ability to connect drug substance, drug product, analytical, material, site, CMO, and regulatory-supporting data flows into one CMC readiness position.
• Strong matrix leadership and executive communication: clear technical options, tradeoffs, implications, owners, recommendations, and escalation asks.
• High comfort operating in ambiguity while preserving functional accountabilities and avoiding duplicate process ownership.
• Strong documentation discipline, traceability mindset, technical-review rigor, and continuous-improvement orientation.
• Experience integrating CMC execution across technical development, MSAT, manufacturing, quality, regulatory, supply, site, and CMO interfaces.
• Strong understanding of vaccine / sterile manufacturing CMC readiness, regulatory-supporting data flows, and cross-functional launch or lifecycle execution.

Responsibilities

• Build and manage the integrated COVID/FLU ASU CMC technical execution and readiness plan across TD, MSAT, Manufacturing, Quality, Regulatory, Supply, internal sites, and CMOs.
• Own the COVID/FLU end-to-end CMC technical readiness view by integrating material readiness, data readiness, evidence readiness, DS-to-DP interface readiness, site / CMO readiness, critical milestones, risks, dependencies, decisions, and action owners into one executable plan.
• Review, interpret, and challenge technical readiness inputs from Research, TD, MSAT, Quality, Regulatory CMC, CMC Writing, Manufacturing, Supply, sites, and CMOs to determine whether data, evidence, assumptions, and handoffs are sufficient to support ASU decisions.
• Coordinate Module 3 handoff readiness, RTQ support readiness, documentation traceability, and evidence-readiness needs with Regulatory CMC, CMC Writing, Quality, TD, MSAT, and functional SMEs.
• Drive adoption and training for the automated CTD authoring tool ahead of the next ASU filing season, ensuring ASU teams are prepared to use the tool for Module 3 authoring, source-document linkage, data traceability, human-in-the-loop review, document verification, and timely evidence handoffs.
• Drive cross-functional follow-through on COVID/FLU ASU technical readiness actions, ensuring technical owners, decision needs, due dates, risks, escalation paths, and go / no-go implications are clear.
• Surface COVID/FLU ASU execution tradeoffs early, including technical, data, regulatory, supply, site / CMO, material, DS-to-DP, and launch-readiness implications.
• Partner with the ASU Portfolio & Governance Operations Lead and ASU Strategy BPO / ALPS to ensure technical readiness, risks, milestones, and decisions are accurately reflected in governance inputs, dashboarding, stakeholder communications, and lessons learned.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior