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 Alexions 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 early candidates in development utilize appropriate analytical tools to enable candidate nomination and utilize strategies and technologies via internal and external partnerships. The ideal candidate will also enable the development of portfolio projects in a phase-appropriate manner while managing the budget and internal resources. 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 Alexions diverse portfolio from pre-clinical to successful licensure.

• Leads interface with research on candidate assessments utilizing current as well as developing new tools (e.g. in silico related biophysical AI based) and approaches to enable appropriate candidate selection for development.

• Enable the development of 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 Alexions 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 Research Analytical Development to build the best-in-class approaches and strategies for developing products in Alexions diverse portfolio.

• 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 considerable time and effort in developing colleagues and the requisite bench strength to deliver on Alexions growing R&D pipeline.

Minimum Qualifications:

Desired Qualifications:

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

When we put unexpected teams in the same room we ignite bold thinking with the power to inspire life-changing medicines! In-person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of four days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZenecas Alexion division we push boundaries in rare disease biopharma by translating complex biology into transformative medicines. Our commitment to transparency objectivity and ethics drives us to meet unmet medical needs. With our global reach and resources we are shaping the future of rare disease treatment helping people live their best lives. Ready to make a difference Apply now!