Head of Parenteral Drug Products (Vice President)

Responsibilities:
- Lead global Parenteral Drug Product organization and delivery of parenteral drug product development from early phase through commercialization and lifecycle management.
- Set strategy and build capabilities for parenteral formulations and aseptic fill/finish (tech transfer; process validation/PPQ readiness).
- Own parenteral strategy/roadmap across modalities (e.g., mAbs, recombinant proteins, peptides, oligos, complex biologics).
- Drive parenteral formulation development (liquid/lyophilized): stability, compatibility, excipient selection, and control strategies.
- Lead aseptic fill/finish and scale-up (sterile filtration, filling technologies, lyophilization cycles, container closure strategy).
- Integrate delivery devices for combination products (e.g., PFS, autoinjectors, pens) including compatibility/performance.
- Own parenteral CMC deliverables for global submissions (IND/CTA/BLA/NDA/MAA and variations); ensure inspection readiness.
- Lead lifecycle management activities (deviation investigations support, CAPA/change control, process robustness, cost-of-goods, supply continuity).
- Establish platform approaches and lead external network strategy (CDMOs/CMOs, component suppliers).

Qualifications/Skills:
- BSc (chemistry/biology/pharmacy/engineering or related) + 25+ years; or MSc + 20+ years; or PhD + 15+ years in relevant industry experience.
- Deep expertise in parenteral biologics DP; aseptic processing/fill-finish; lyophilization development; container closure systems and key risks.
- Proven global parenteral CMC regulatory strategy/filings and tech transfer/PPQ/commercial troubleshooting.
- Strong leadership, strategic thinking, communication, cross-functional/team management, and negotiation.

Education/Requirements (from above):
- Degree in relevant scientific/engineering discipline; demonstrated regulatory document writing and quality-process knowledge.