Head of Product Development (m/w/d)

Director, Injectable Drug Product Development at Alexion Pharmaceuticals, Inc.

Formulation and process development, product integration, and manufacturing of patient‑centered injectable drug products for Alexion’s portfolio from pre‑clinical to successful licensure.

Lead interface with Operations, CMC Project Management, Clinical Development, and Regulatory teams on life‑cycle management opportunities.

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

Oversee technology transfer of Alexion’s portfolio, providing specialized engineering solutions for equipment and processes.

Mentor and support colleagues in a matrix team for efficient and successful drug product development and manufacturing.

Provide regulatory filing expertise, including interactions with regulators, inspections, and audits.

Work with leadership on drug product development strategies within PDCS and partner with Operations, Regulatory Affairs, and Commercial organizations.

Invest time and effort in developing colleagues and building Alexion’s growing R&D pipeline.

BS or equivalent in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with relevant experience.

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 direct experience developing approaches to enable drug product development for early and late‑stage programs through licensure.

Proficiency in current approaches for formulation and drug product process development, manufacturing processes and equipment, and applying these to efficient approaches that ensure product licensure.

Knowledge of current regulatory guidelines and cGMP requirements.

Qualified retirement program [401(k) plan]

Paid vacation, holidays, and paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage following applicable plan terms.

Positions also offer short‑term incentive bonus opportunities, eligibility for equity‑based long‑term incentive programs, retirement contributions, and commission payment eligibility.

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.

#J-18808-Ljbffr Alexion Pharmaceuticals, Inc.