Director, Injectable Drug Product Development,

You Will:

• Formulation and process development, product integration, and manufacturing of patient-centered, unique injectable drug products for Alexion's diverse portfolio from pre-clinical to successful licensure.

• Lead interface with Operations, CMC Project management, Clinical Development, Regulatory on life cycle management opportunities.

• Develop drug product delivery strategies through internal/external partnerships and product integration into drug/device combination products.

• Alexion enables the department to progress its diverse portfolio. This portfolio spans peptide, nucleic acid, protein-based modalities, as well as modalities for gene delivery. People present these modalities in multiple forms, including liquid and lyophilized dosage forms in vial, prefilled syringe, and cartridge-based presentations.

• Ensure tech transfer of Alexion's portfolio with specialized input on engineering solutions for equipment and processes.

• Review and develop drug product techology roadmap and manage important investments.

• Assist and mentor colleagues in a matrix team for efficient and successful drug product development and manufacturing in a phase appropriate manner.

• Partner with functions across Alexion to build the best strategies for developing products in Alexion's diverse portfolio.

• Provide subject matter expertise for preparing regulatory filings, regulatory interactions including inspections, audits and is accountable for the technical content of the relevant drug product sections of regulatory submissions.

• Work with the Head on the development on drug product development strategies within PDCS and with partners in Operations, Regulatory Affairs, and Commercial organizations.

• Devote considerable time and effort in developing colleagues and the requisite to achieve Alexion's growing R&D pipeline.

You Have:

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

• You 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 of direct experience developing approaches to allow drug product development for early and late-stage programs through licensure.

• At least 5 years of experience managing a team of scientists and engineers at different levels (directly or in a matrix team) Ensuring their career growth.

• Must be proficient in current approaches for formulation and drug product process development, manufacturing processes and equipment, and applying these to developing efficient approaches to ensure product licensure.

• Knowledge of high concentration protein formulation development, aseptic processes, to provide vial, prefilled syringe, cartridge presentations as liquid and lyophilization dosage forms is important.

• Knowledge of current regulatory guidelines and cGMP requirements is necessary .

Benefits offered include:

• A qualified retirement program [401(k) plan]

• Paid vacation, holidays, and paid leaves

• Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans.

#LI-Onsite #Alexion

Date Posted

Closing Date

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