Senior Director, Injectable Drug Product Development

The position leads and directs the formulation and process development, product integration, and manufacturing of patient-centered injectable drug products for Alexion’s diverse portfolio spanning synthetic, peptide, genomic medicine and protein-based modalities across various liquid, lyophilized, vial, prefilled and cartridge-based presentations. A key focus area would be on the successful product integration into drug/device combination product. The position will also enable the assessment of appropriate drug product development and delivery strategies and technologies via internal and external partnerships, managing the budget and internal resources for the development of clinical and commercial phase drug products. The ideal candidate will also enable the development of portfolio projects in a phase-appropriate manner.  The position will be a member of the Injectable Drug Product Management team and will need to collaborate and network with other departments within Product Development and Clinical Supplies (PDCS) as well as with Research, Alexion Operations, Clinical Development, Quality and Regulatory organizations.  

You will be responsible for: 

• Direct formulation and process development, product integration, and manufacturing of patient-centered, differentiated injectable drug products for Alexion’s diverse portfolio from pre-clinical to successful licensure. 

• Leads drug product development and delivery strategies through internal/external partnerships as well as product integration into drug/device combination products 

• Enables the department to progress Alexion’s diverse portfolio spanning peptide, nucleic acid, protein-based modalities, modalities for gene delivery as liquid & lyophilized dosage forms in vial, prefilled syringe, and cartridge-based presentations.  

• Assist and mentor colleagues for efficient and successful development and technology transfers of Drug Products to internal and external manufacturing organizations in a phase appropriate manner.  

• Partners with functions across Alexion with key focus on Clinical Supplies Management, Clinical Operations, Technical Services and Manufacturing sites to build the best in class approaches and strategies for developing products in Alexion’s diverse portfolio 

• Partners with the Tech Transfer organization to develop strategies for process characterization and process validation studies for late-stage programs to enable robust commercial manufacturing processes. 

• Provide subject matter expertise for the preparation of regulatory filings, regulatory interactions including inspections, audits and is accountable for the technical content of the relevant drug product sections of regulatory submissions. 

• Works with the Head on the development on drug product development strategies within PDCS and with key stakeholders in Global Operations, Global Regulatory Affairs, and Commercial organizations.  

• Devotes significant time and effort in developing colleagues and the requisite bench strength to deliver on Alexion’s growing R&D pipeline. 

Minimum Qualifications:

• MS or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related discipline with relevant experienc