Senior Director, Bioprocess / Process Development – Pivotal Drug Substance
Core
Lead the development, characterization, scale-up, and lifecycle management of cell culture and purification processes for late-stage biologics (mAbs, BiTEs, bispecifics) to enable commercial advancement.
Role type
Senior Director, Bioprocess / Process Development
Builds
Commercial drug substance processes for biologics
Domain
Biopharmaceuticals / Bioprocessing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> production ML models (Incorrect mapping in thought, correcting to: physical/clinical work -> production ML models is wrong. Correct mapping: physical/clinical work is not right. The deliverable is physical/clinical work? No. It is production ML models? No. It is product features? No. It is dashboards & analysis? No. It is research? No. It is client delivery? No. It is infrastructure? No. It is physical/clinical work? No. Wait, the options are: production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work. This role develops drug substance processes. This is closest to 'product features' (the drug substance) or 'infrastructure' (the process). Given the context of 'process development' for 'drug substance', 'product features' is the best fit as it defines the product's manufacturing attributes. However, 'infrastructure' might fit the 'process' aspect. Let's look at the options again. 'product features' usually implies software. 'physical/clinical work' is for nurses/doctors. 'client delivery' is for consulting. 'research' is for early stage. 'infrastructure' is for IT/Cloud. 'dashboards & analysis' is for data. 'production ML models' is for AI. None fit perfectly. But 'product features' is often used for the tangible output. Let's select 'product features' as the drug substance is the product feature being developed. Actually, looking at standard taxonomy for this type of role, it's often 'product features' (the drug) or 'infrastructure' (the facility/process). Let's go with 'product features' as the primary output is the drug substance.
Required skills
Bioprocess development, Cell culture bioreactor processes, Downstream purification, Process characterization, Lifecycle management, Control strategy development, Regulatory filing authoring, Team leadership, Portfolio prioritization, Cross-functional program leadership
Preferred skills
PhD in Biochemistry/Biochemical/Chemical Engineering, Late-stage biologics development expertise, Statistical data analysis, Scientific community engagement, Talent development
Technologies
Bioreactors, Purification systems, Regulatory databases
Responsibilities
Lead multi-site drug substance organization, Recruit and develop team, Advance integrated drug substance processes, Partner on process transfer, Author global regulatory filings, Drive innovative bioprocess technologies, Contribute to scientific eminence via publications/patents
Seniority
Senior Director, hands-on IC with strategic leadership
