Director, Formulation and Process Development

AstraZeneca • New Haven, CT

1d • Onsite

About The Position

You will lead and direct the formulation and process development of patient-centered injectable drug products. These products are for Alexion's diverse portfolio, which spans synthetic, peptide, genomic medicine, and protein-based modalities in multiple formats, including liquid, lyophilized, vial, prefilled, and cartridge-based presentations. You will also lead life cycle development opportunities, provide expertise in technology transfer and drug product engineering and technology development with internal and external partnerships. You will also ensure the development of portfolio projects in a phase-appropriate manner while managing the budget and interface partners. You will be a member of the Injectable Drug Product Management team and will need to collaborate and network with other departments within Product Development and Clinical Supplies (PDCS). Additionally, it will need to collaborate and network with Alexion Operations, Clinical Development, Quality, and Regulatory organizations.

Requirements

• Must have a 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.
• Must be 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 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.
• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• commission payment eligibility

What This Job Offers

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