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 early candidates in development, utilizeappropriate analytical tools to enable candidate nomination and utilizestrategies 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 Alexion’s 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 Alexion’s diverse portfolio spanningpeptide, 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 Alexion’s 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 Alexion’s growing R&D pipeline.
Minimum Qualifications:
BS or equivalent in Pharmaceutical Sciences, Bio/Chemical Engineering, Biochemistry, or related discipline with relevant experience
The successful candidate will have number of years of drug product development experience in formulation and process development and technology transfer for mAbs, proteins, peptides. synthetics and genomic medicine products
At least 8 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.
Atleast 5 years of experience in managing a team of scientists and engineers at different levels enabling their career growth and development.
Must be proficient in current approaches for candidate assessment, formulation and process development, process characterization and applying these to developing efficient and robust approaches to enable product licensure.
Deep knowledge of high concentration protein formulation development, aseptic processes, to providevial, prefilled syringe, cartridge presentations as liquid and lyophilization dosage forms is essential.
Knowledge of current regulatory guidelines and cGMP requirements is essential.
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. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca's 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!
Date Posted
29-Jul-2025Closing Date
31-Aug-2025Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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