Director, Injectable Drug Product Development,

Alexion Pharmaceuticals, Inc.; New Haven (CT); Sur place; USD 175 000 - 263 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Paid vacation and holidays

Health benefits including medical and dental coverage

Résumé du poste

A leading biopharmaceutical company in Connecticut is seeking a Director of Injectable Drug Product Development. This role entails leading formulation and process development for injectable products, collaborating with cross-functional teams, and overseeing technology transfer. Candidates should have at least 8 years of experience in drug product development and 5 years managing teams. The position offers a competitive salary range of $175,000 to $263,000, along with benefits including health coverage and retirement plans.

Qualifications

• Minimum of 8 years of drug product development experience.
• At least 5 years managing a team in drug product development.
• Proficiency in drug product process development and manufacturing.

Responsabilités

• Lead formulation and process development of injectable drug products.
• Collaborate across departments for successful product development.
• Oversee technology transfer for drug product manufacturing.

Connaissances

Drug product development

Team management

Formulation and process development

Aseptic processes

Regulatory knowledge

Formation

BS or equivalent in Bio/Chemical Engineering, Pharmaceutical Sciences or related discipline

Description du poste

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

Date Posted: 15-Dec-2025 | Closing Date: 08-Jan-2026

Responsibilities

• 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.
• Review and develop a drug product technology roadmap and manage critical investments.
• Mentor and support colleagues in a matrix team for efficient and successful drug product development and manufacturing.
• Collaborate with functions across Alexion to build optimal strategies for developing products in its diverse portfolio.
• 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.

Qualifications

• 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.
• At least 5 years of experience managing a team of scientists and engineers at different levels (directly or in a matrix team), ensuring career growth.
• 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 high‑concentration protein formulation, aseptic processes, and vial, prefilled syringe, cartridge presentations in liquid and lyophilized dosage forms.
• Knowledge of current regulatory guidelines and cGMP requirements.

Benefits

• 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.

The annual base salary for this position ranges from $175,000 to $263,000, with variability based on market location, job knowledge, skills, and experience. Positions also offer short‑term incentive bonus opportunities, eligibility for equity‑based long‑term incentive programs, retirement contributions, and commission payment eligibility.

Our 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.