Director, Synthetic Drug Substance Manufacturing

This is what you will do:

• The successful candidate will be responsible for technical oversight at Contract Manufacturing Organizations (CMOs) used by Alexion to produce commercial and clinical synthetic drug substance.  This position provides strong scientific leadership for all aspects of technology transfer, validation, process scale-up, inspection, process monitoring, and process troubleshooting for manufacturing activities. There is strong emphasis on continuous process improvement with this role.

The position also fosters effective cross-functional working relationships with internal and external groups in operations, chemical process development, analytical sciences, and quality assurance for the technology transfer of new products and providing support for regulatory submissions related to commercial and clinical products manufactured at CMOs.

You will be responsible for:

• Leading and building the Synthetic Drug Substance Manufacturing team.   
• Ensure that all processes are appropriately validated and approved for manufacturing and partner with regulatory and quality assurance colleagues to ensure that processes are maintained in a validated and compliant state throughout their lifecycle. 
• Provide leadership to process validation program for all synthetic drug substance manufacturing processes at CMOs. Provide technical input to process development for defining the critical process parameters of new processes.
• Lead the generation and review of CMC sections of the NDA/MAA and other technical documents for regulatory agency submission for commercial CMO sites.
• Provide significant technical depth to support continuous process improvement to maximize yield and lower cost of goods (CoGs).
• Provide technical direction for the identification and implementation of process optimization initiatives as well as efficiency and capacity improvements at CMOs.
• Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail.  Communications will be both written documents, and in formal and informal oral presentations.
• Up to 20% international travel may be required.

You will need to have:

• Minimum of 15 years’ experience in a technical or manufacturing role in the pharmaceutical industry with a major focus on synthetic modalities (small molecule, peptide, oligonucleotide, and spray dried dispersions).
• High level of technical expertise in pharmaceutical manufacturing across multiple technology and processing areas (drug substance, oral solid dose, aseptic filling).
• Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing.
• Broad experience of technology transfer and process validation management and continuous improvement
• Strong communication skills enabling him/her to influence both internal and external partners.
• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
• Advanced degree (MS, PhD) in Scientific (Biochemistry, Biology, Chemistry, Pharmacy) or Engineering (Chemical, Mechanical) related field
• Lean six sigma experience is preferred.

We would prefer for you to have:

• Knowledge of Quality by Design (QbD) principles, including the use of multivariate data analysis and/or first-principles process modeling in conjunction with predefined multivariate operating ranges (“Design Spaces”) in a commercial manufacturing setting.

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.