External Manufacturing Site Lead at Biogen

Seoul, South Korea, South Korea

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Specialized knowledge and expertise in pharmaceutical/biologics manufacturing discipline
Deep experience integrating related disciplinary knowledge
Strong technical expertise in process control strategy and tactical execution of manufacturing operations for a specific modality and/or manufacturing node at external supplier sites
Technical subject matter expert in modality/node corresponding to manufacturing site designation
Exposure across all role requirements for Operations and Supplier Relationship Management
Education (Minimum): Bachelors > 10 years, Masters > 8 years, PhD > 5 years
Experience with CDMOs and/or CLOs in pharmaceutical and/or medical device manufacturing, including site selection (RFx activities), contract negotiation and execution, business performance reviews, and partner governance
Ability to analyze scientific datasets, solve complex manufacturing and compliance issues, develop/implement/execute CAPAs, and identify/lead business process optimization

Provide technical and operational oversight for manufacturing operations at intermediate complexity CDMO sites
Manage global change controls and deviations
Create, update, and communicate technology transfer deliverables and project metrics at external sites
Author/review site-specific Continuous Process Verification (CPV) reports
Collaborate with senior leadership (internal/external) and cross-functionally to ensure alignment and delivery of manufacturing objectives
Lead continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness
Functionally lead the primary vendor engagement team (Person-In-Plant where needed) and drive/monitor supplier performance
Lead/facilitate/coordinate tech transfer activities, including process/facility fit, control strategy transfer, manufacturing readiness, production/testing, material disposition, and supplier interactions
Act as technical resource for modality/node, managing project schedule, TT plan, risks/mitigation tracking, and escalations
Ensure compliance of external technical operations with Biogen procedures and cGXP regulations/guidelines
Ensure external manufacturing protocols/reports comply with agency expectations
Lead supplier relationship management from contract development/execution/delivery/metrics readout and governance, owning vendor team engagement with GM sponsorship