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.

The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have. A key focus area is the successful product integration into drug/device combination products. The role also involves assessing appropriate drug product development and delivery strategies and technologies via internal and external partnerships, managing budgets and resources for clinical and commercial phase drug products. The ideal candidate will enable development of portfolio projects in a phase-appropriate manner and collaborate across departments within Product Development and Clinical Supplies (PDCS), as well as with Research, Operations, Clinical Development, Quality, and Regulatory organizations. You will be responsible for: Direct formulation and process development, product integration, and manufacturing of injectable drug products from pre-clinical to licensure. Leading drug product development and delivery strategies through partnerships and product integration into drug/device combinations. Advancing Alexion’s portfolio across peptide, nucleic acid, protein-based, and gene delivery modalities in various dosage forms. Mentoring colleagues for efficient development and technology transfer to manufacturing organizations. Partnering with Clinical Supplies Management, Operations, Technical Services, and Manufacturing to develop best practices. Collaborating with Tech Transfer to develop strategies for process characterization and validation for late-stage programs. Providing expertise for regulatory filings, inspections, audits, and ensuring technical accuracy of drug product sections. Working with leadership on drug development strategies and engaging with global stakeholders. Developing colleagues and building bench strength for R&D pipeline growth. Minimum Qualifications: MS or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related with relevant experience. Experience leading drug product development, especially in technology transfer and manufacturing support for mAbs, proteins, peptides, synthetics, and genomic medicines. At least 12 years of experience managing a team of scientists/engineers in drug product development for early and late-stage programs. Proficiency in candidate assessment, formulation, process development, and regulatory compliance. Deep knowledge of high concentration protein formulations, aseptic processes, and dosage forms including lyophilized products. Desired Qualifications: PhD or equivalent in relevant disciplines with experience. We foster an inclusive environment where all applicants are welcome. We work a minimum of four days a week in the office, balancing flexibility with collaboration. Join us in advancing rare disease treatments and making a difference in patients' lives. Date Posted: 29-Jul-2025 Closing Date: 05-Aug-2025 We are committed to equal employment opportunities and welcome applications from all qualified candidates, including those requiring accommodations for disabilities.

#J-18808-Ljbffr