Director, Formulation and Process Development

You will lead and direct the formulation and process development of patient-centered injectable drug products.These products are for Alexions 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 provideexpertisein 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.

You Will:

• Formulation and process development and manufacturing of patient-centered unique injectable drug products for Alexions diverse portfolio from pre-clinical to successful licensure.

• Develop drug productdevelopmentstrategies through internal/external partnerships and product integration into drug/device combination products.

• Enablethe progression of Alexionsdiverse portfoliothatspans peptide nucleic acid protein-based modalities as well as modalities for gene deliveryasliquid and lyophilized dosage forms in vial prefilled syringe and cartridge-based presentations.

• Ensure tech transfer of Alexions portfolio with specialized input on engineering solutions for equipment and processes.

• Review and develop drug producttechnologyroadmap and manage important investments.

• Mentorand developcolleagues in a matrix team for efficient and successful drug product development and manufacturing in a phaseappropriate manner.

• Partner with functions across Alexion to build the best strategies for developing products in Alexions diverse portfolio.

• Provide subject matterexpertisefor 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 developmentondrug product development strategies within PDCS and with partners in Operations Regulatory Affairs and Commercial organizations.

You Have:

• 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 withendtoenddrug product developmentexperience(spanning formulation process development quality attribute assessmenttechtransferand manufacturing support)formAbsfusionproteinsinjectablepeptides/syntheticsprograms.

• At least 5 years of experience managing a team of scientists and engineers atdifferent 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 equipmentregulatory expectationsand applying these to developing efficient approaches to ensure product licensure.

• Knowledge of high concentration protein formulation development aseptic processes vial prefilled syringe cartridge presentationsliquid 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.

Additionaldetails 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 $175000 to $263000. However base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility toparticipatein our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles).

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