ASU CMC Technical Integration Lead

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).

• Drive integrated CMC technical execution for the COVID/Flu ASU.
• Own the end-to-end technical integration required to protect filing- and launch-critical ASU commitments and improve execution year over year.

Here’s What You’ll Do

• 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.

Primary Deliverables

• Coverage of the COVID/FLU ASU integrated CMC technical execution plan, readiness view, and critical path aligned to the ASU lifecycle timeline.
• Coverage of the COVID/FLU material / data / evidence readiness assessment, including Module 3 handoff, RTQ support readiness, documentation traceability, DS-to-DP interface readiness, and site / CMO readiness status.
• Coverage of the COVID/FLU ASU technical risk, dependency, decision, escalation, and action-owner log that captures technical rationale, open assumptions, readiness gaps, and go / no-go implications.
• Coverage of the governance-ready COVID/FLU ASU technical tradeoff summaries, options, implications, recommendations, and escalation asks.
• Coverage of the COVID/FLU ASU lessons learned and continuous-improvement recommendations for future ASU cycles and the ASU Engine / ALPS operating interface.

Key Interfaces

• Research, TD, MSAT, Manufacturing, Quality, Regulatory CMC, CMC Writing, Supply, sites, and CMOs for COVID/FLU ASU execution readiness inputs and follow-through.
• DS / DP technical owners, APLs, MSAT Materials, Product Team Lead, DS / DP NPI owners, Site Support, and functional SMEs to integrate technical assumptions and readiness inputs without taking over their functional deliverables.
• ASU Strategy / ALPS for lifecycle-project process, official cadence, dashboarding, stakeholder communication, and governance alignment.

Here’s What You’ll Need (Basic 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.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• 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.

Pay & Benefits

• Pay Range: $142,500.00 - $256,500.00.
• Benefits: Competitive healthcare, family planning benefits, generous paid time off, savings and investments, and location-specific perks and extras.