Job Description

The Opportunity

Building on the success of our recent US approval for HEMGENIX\xc2\xae (etranacogene dezaparvovec-drlb), the world\xe2\x80\x99s first gene therapy for hemophilia B, you will join a lean but growing team committed to bringing new gene therapies to patients. \xe2\x80\x8bAs a successful Senior Lead Fill & Finish Gene Therapy, you ensure cross-site, cross-value stream, and intercompany tech and knowledge transfer for the area of Fill & Finish of Gene Therapy Molecules across projects. You deliver and contribute to the robustness of the process, design of process equipment, technology transfer, technology selection for manufacturing, and PAT systems. Work onsite in the greater Boston, Massachusetts area is required.

The Role

Champion transformation of process engineering, manufacturing technologies & innovation at CSL.

Contribute to and lead the Fill & Finish aspects of the tech transfer of products to alternate sites including CMOs

Support site-specific Root Cause Analysis in the manufacturing process and process technology and resolving challenges in the process

Lead process improvement for yield, quality and time

Manage process questions during tech transfer from sending to receiving site

Answer technical questions from tech transfer perspective regarding Fill & Finish equipment

Manage local and global capacity expansion projects to provide a reliable supply for our patients

Make decisions within capital projects and guide progress forward. Support collaboration within the projects.

Provide process engineering support to front end design in Fill & Finish capital projects on Gene Therapy products

Establish global design standards for the Fill & Finish area in collaboration with company partners

Scout and implement new technologies for Fill & Finish of gene therapy technologies in collaboration with R&D, and MS&T

Contribute to the business success by continuous improvement.

Expected to take a leadership role in project teams and be an active participant (including decision-taking) in an intercompany, cross-site, cross-value stream, and intra-value stream projects

Be a role model at expected behaviors and practices following our CSL values and CSL Guidelines of health, safety, and environment

Your skills and experience

You are a passionate technology partner who leads programs and projects by proactive, positive and self-responsible approach.

The below competencies furthermore contribute to your success:

University degree in chemical or process engineering field

>10 years of work experience in the pharmaceutical industries (experience in the area of Aseptic Filling and Engineering for Aseptic Fill & Finish Area)

GMP experience and awareness of industry practices and trends in the field

Track record in managing projects, programs and manufacturing processes in a regulated environment and managing performance and delivering business value

Ability to manage competing priorities and agendas

Excellent focus and collaborative mindset, ability to inspire others and exemplifying CSL employee brand and values

Our Benefits

We encourage you to make your well-being a priority. It\xe2\x80\x99s important and so are you. Learn more about at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about .

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL.

Do work that matters at CSL Behring!

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