As Drug Substance (DS) CDMO Relationship Manager, you will provide dedicated logistics, scheduling, and meeting-management support for CDMO partnerships for drug substance vendors across late-stage and early-phase programs. Given the criticality of drug substance supply continuity, this role requires a single, embedded External Manufacturing specialist who owns the day-to-day vendor relationship, drives schedule and quality performance, and serves as the primary escalation point for the DS CDMO. This dedicated ownership frees senior leadership to focus on strategic CDMO oversight, technical risk management, and portfolio-wide program delivery.
Key Responsibilities:
DS Vendor Relationship Management
- Serve as the primary point of contact for the DS vendor, owning day-to-day interactions and triaging communications with support and guidance from External Manufacturing leadership.
- Own scheduling and logistics for recurring meetings with the DS vendor (joint technical meetings, JSCs), including calendar coordination across companies and time zones.
- Own batch record / GMP documentation logistics for the DS vendor – tracking review/approval cycle status and driving resolution of bottlenecks.
- Coordinate travel logistics for site visits and workshops with the DS vendor (e.g., FMEA sessions, technical transfer visits), representing EM as needed.
- Maintain the master tracker of DS vendor meeting cadences, deliverables, and deadlines for the EM leadership team.
- Own document routing/version control for DS vendor meeting materials, decks, and governance packages.
- Lead onboarding logistics for any new scope added to the DS vendor engagement (kickoff meeting coordination, distribution list setup, SharePoint/Teams site management).
DS Vendor Performance & Governance
- Assist internal QA organization on Deviation/CAPA tracking administration for the DS vendor – maintaining status trackers, chasing owners for updates, and compiling status for governance reviews (tracking only, not authoring technical content).
- Collaborate with PD/MSAT & QA in pulling recurring technical KPIs and quality performance data for the DS vendor into standard templates ahead of JSCs.
- DS vendor scorecard/dashboard maintenance – updating recurring performance scorecards (OTIF, yield, deviation rates) with vendor-supplied data ahead of JSCs.
- Change control logistics – tracking the DS vendor's change request status (submitted, under review, approved, implemented) and routing signatures.
- Audit and inspection support – logistics coordination (travel, agendas, document requests) for DS vendor audits.
- Provide details to support dashboard updates and internal forums for leadership review.