Sr. Director, Injectable Drug Product Development

This is what you will do:

The position leads and directs the technology transfer, manufacturing support and validation of patient-centered injectable drug products for Alexion’s diverse portfolio spanning synthetic, peptide, nucleic acid, adeno-associated virus (AAV) and protein-based modalities across various liquid, lyophilized, vial, prefilled and cartridge-based presentations. A key focus area would be on the development and manufacturing of drug product which needs to be developed as drug/device combination products The position will work with the Head to assess and optimize the drug product technology transfer and manufacturing support in internal and external manufacturing sites, managing the budget and internal resources required to accomplish the same. 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 Global Operations (Technical Services, Validation), and Regulatory organizations.

You will be responsible for:

• Directs technology transfer, manufacturing support and validation of patient-centered, differentiated injectable drug products for Alexion’s diverse portfolio from pre-clinical to successful licensure.
• Recognized as a subject matter expert around drug product process development and manufacturing for Alexion’s diverse portfolio spanning synthetic, peptide, nucleic acid, AAV and protein-based modalities across various liquid & lyophilized, vial, prefilled syringe, and cartridge-based presentations. Drug Product Development of emerging modalities of Cell and non-viral gene therapy are included in the future scope of responsibilities
• Assist and mentor colleagues for efficient and successful technology transfers of Drug Products to internal and external manufacturing organizations in a phase appropriate manner.
• Partners with functions across Alexion – Global Technical Operations, Technical Services and Validation to build the best in class approaches and strategies for manufacturing Alexion’s diverse portfolio
• Participates in developing drug product development and delivery strategies through internal/external partnerships as well as product integration into drug/device combination products
• Works with the broader organization and develops strategies for process characterization and process validation studies for late-stage programs to enable robust commercial manufacturing processes.
• Creates network within and outside Alexion with manufacturing related SMEs to enable development of best in class manufacturing approaches and technologies
• 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.

You will need to have:

• The successful candidate will have number of years of drug product development experience with direct experience leading a team in technology transfer and manufacturing support for mAbs, proteins, peptides. Synthetics and AAV products and preferably newer modalities of cell and non-viral gene therapy
• At least 12 years of experience in managing a group of drug product development scientists or engineers with direct experience of developing processes to enable drug product manufacturing for early as well as late-stage programs through licensure
• At least 12 years of experience in managing a team of scientists and engineers at various levels enabling their career growth and development
• Must be proficient in scale-up/scale-down approaches in process characterization and applying these to developing and executing process validation strategies to enable robust commercial manufacturing processes.
• Strong established expertise in developing aseptic processes for prefilled syringe, cartridge and vial based liquid and lyophilized products is required. Knowledge of current regulatory guidelines and cGMP requirements is essential. Experience in manufacture of high-concentration protein-based dosage forms is desired.
• Direct experience in preparing regulatory submissions including BLA/MAAs and engaging with regulatory inquiries is required.

We would prefer for you to have:

• Must have a BS/MS/PhD or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related discipline with relevant experience

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.