Director, Formulation and Process Development

AstraZeneca • New Haven, CT

1d • Onsite

About The Position

This role will lead and direct the formulation and process development of patient-centered injectable drug products for Alexion's diverse portfolio, spanning synthetic, peptide, genomic medicine, and protein-based modalities in multiple formats. The position involves leading life cycle development, providing expertise in technology transfer, and drug product engineering. The Director will ensure phase-appropriate development of portfolio projects, manage budgets, and interface with partners. This role is part of the Injectable Drug Product Management team and requires collaboration with various internal departments (Product Development and Clinical Supplies, Alexion Operations, Clinical Development, Quality, and Regulatory) and external partners.

Requirements

• BS or equivalent in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with relevant experience
• At least 8 years of experience in managing a group of drug product development scientists or engineers with end to end drug product development experience (spanning formulation, process development, quality attribute assessment, tech transfer and manufacturing support) for mAbs, fusion proteins, injectable peptides/synthetics programs.
• At least 5 years of experience managing a team of scientists and engineers at different levels (directly or in a matrix team) and ensuring their career growth.
• Proficient in current approaches for formulation and drug product process development, manufacturing processes and equipment, regulatory expectations and applying these to developing efficient approaches to ensure product licensure.
• Knowledge of high concentration protein formulation development, aseptic processes, vial, prefilled syringe, cartridge presentations, liquid and lyophilization dosage forms is important.
• Knowledge of current regulatory guidelines and cGMP requirements is necessary.

Responsibilities

• Formulation and process development and manufacturing of patient-centered, unique injectable drug products for Alexion's diverse portfolio from pre-clinical to successful licensure.
• Develop drug product development strategies through internal/external partnerships and product integration into drug/device combination products.
• Enable the progression of Alexion’s diverse portfolio that spans peptide, nucleic acid, protein-based modalities, as well as modalities for gene delivery as 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 technology roadmap and manage important investments.
• Mentor and develop 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.

Benefits

• A qualified retirement program [401(k) plan]
• Paid vacation, holidays, and paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Short-term incentive bonus opportunity
• Eligibility to participate in our equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees