Director, Injectable Drug Product Development,

AstraZeneca•New Haven, CT

8d•Onsite

About The Position

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. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.The annual base salary for this position ranges from $175,000 to $263,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). #LI-Onsite #Alexion Date Posted 15-Dec-2025 Closing Date 08-Jan-2026 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Requirements

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

Responsibilities

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.
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.

Benefits

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.
Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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