ASU CMC Technical Integration Lead

About the role

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).

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.

Qualifications

• 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.

Benefits

Competitive healthcare, plus voluntary benefit programs to support your unique needs.
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.

Pay

$142,500.00 - $256,500.00.