CMC Project Manager – Late-Stage Biologics

BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION Our Biotechnology Client is seeking an experienced CMC Project Manager to provide execution leadership across drug product and device workstreams supporting BLA readiness and late‐stage commercialization activities.This engagement is aligned to regulatory filing milestones, including PPQ execution, device verification and validation, and design control phase completion.This critical CMC Project Manager will step into established project plans and roadmaps (Smartsheet‐based) and drive cross‐functional coordination, vendor oversight, and milestone execution through BLA submission and related post‐PPQ activities.This role will report into the Senior Director of CMC Project Management.DUTIES/DELIVERABLES and KEY FOCUS AREAS Step into established Smartsheet project plans and maintain execution momentumFacilitate cross‐functional meetings across CMC, device engineering, quality, and external vendorsMaintain risk registers and contingency plansProvide executive‐ready updates aligned to filing timelinesManage action items/accountable parties across internal and external stakeholders to maintain project schedule integrityDrug Product Workstreams (Focus Area) Coordinate documentation and close‐out preparation supporting BLA submissionEnsure alignment between manufacturing, validation documentation, and regulatory timelinesUpdate integrated project timelines through BLACoordinate PPQ documentation readiness packageWeekly progress reporting and risk trackingBLA‐aligned CMC milestone tracking dashboard and PPQ readiness trackerCross‐functional action log with risk mitigation plansExecutive‐level status updates tied to validation timelinesDevice Development & Design Controls (Focus Area) Documentation coordination across device engineering, quality, and regulatoryIntegrated device validation readiness plan, design control phase exit trackerUpdates to Verification & validation milestone dashboardCross‐functional documentation coordination (design history file readiness)BLA‐aligned device submission trackingMUST HAVES – QUALIFICATION SUMMARY Minimum of 6+ years of experience in CMC project management within biotechnology or pharmaceutical spaceProficiency with SmartsheetDemonstrated experience supporting late‐stage biologics programsStrong background in drug product development and external CMO oversightAbility to coordinate across multiple external vendors and internal SMEsComfortable operating in nimble, fast‐moving environments and wearing multiple hatsExperience with device development processes preferred, including: Design controlsVerification and validationCombination product familiarity preferredTRAVEL & LOCATION REMOTE.START & TERM Immediate start. Initial contract period through September of 2027 with potential to extend.#J-18808-Ljbffr