Head of Parenteral Drug Products (Vice President)

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Job Description

OBJECTIVES/PURPOSE:

• Leads the global Parenteral Drug Product organization and delivery of parenteral drug product development from early phase through commercialization and lifecycle management.

• Sets strategy and builds capabilities for robust parenteral formulations and aseptic fill/finish processes, including tech transfer and process validation/PPQ readiness.

• Partners with Device Development (as needed) and key stakeholders (GSQ, Quality, Regulatory CMC, Commercial, R&D, Supply Chain) and external partners to deliver high-quality parenteral and combination products.

ACCOUNTABILITIES:

• Owns the global Parenteral Drug Product strategy and capability roadmap across modalities (e.g., mAbs, recombinant proteins, peptides, oligos, complex biologics) to deliver clinically and commercially viable parenteral products.

• Accountable for parenteral formulation development (liquid and lyophilized) including stability, compatibility, excipient selection, and robust control strategies aligned to target product profile and patient use.

• Leads development of aseptic fill/finish processes and scale-up, including sterile filtration, filling technologies, lyophilization cycle development, and container closure strategy through PPQ and commercialization.

• Ensures integration with Device Development for combination products and delivery systems (e.g., PFS, autoinjectors, pens) including drug-product/device compatibility and performance requirements.

• Owns parenteral CMC deliverables for global submissions (IND/CTA/BLA/NDA/MAA and variations), ensuring high-quality module content, agency interactions, and inspection readiness.

• Drives lifecycle management for commercial parenteral products: deviation investigations support, CAPA contributions, change control, process robustness, cost-of-goods improvements, and supply continuity in partnership with GSQ and manufacturing sites/CMOs.

• Establishes platform approaches for parenteral development (e.g., platform formulations, standard CCS options, leachables/extractables strategy alignment, standard lyophilization approaches) to accelerate pipeline delivery.

• Leads external network strategy for parenteral DP (CDMOs/CMOs, component suppliers), including technical governance, performance metrics, and risk mitigation.

• Builds and develops a high-performing global organization; defines operating mechanisms, talent strategy, and resourcing across programs and geographies.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

• Deep expertise in parenteral biologics drug product development (liquid and lyophilized), including formulation science, stability, aggregation/particulates control, and analytical/biophysical characterization interface.

• Strong knowledge of aseptic processing and fill/finish manufacturing science (sterility assurance, contamination control strategy, process controls, equipment/technology selection).

• Demonstrated expertise in lyophilization development (cycle design, scale-up, CPP/CQA linkage, process robustness) and/or other stabilization approaches.

• Experience with container closure systems for parenterals (vials, syringes, cartridges) and key technical risk areas (silicone oil, tungsten, delamination, extractables/leachables, compatibility).

• Proven track record in global parenteral CMC regulatory strategy and filings, including successful licensure and post-approval changes.

• Strong capability leading tech transfer to internal sites and/or CMOs and supporting PPQ, commercial troubleshooting, and lifecycle change execution.

Leadership

• Strategic thinking, facilitative leadership.

• Executive leadership presence and confidence.

• Enterprise level leadership with the ability to inspire, motivate and drive results.

• Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.

• Ability to assemble and manage a