Senior Lead Fill & Finish Gene Therapy

The Opportunity:

Building on the success of our recent US approval for HEMGENIX® (etranacogene dezaparvovec-drlb), the world’s first gene therapy for hemophilia B, you will join a lean but growing team committed to bringing innovative gene therapies to patients. ​As a successful Senior Lead Fill & Finish Gene Therapy, you actively 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.

The Role:

• Championing transformation of process engineering, manufacturing technologies & innovation at CSL.
• Actively 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 as well as resolving issues/challenges in process
• Lead and manage process improvement with respect to yield, quality and time
• Lead and manage process questions during tech transfer from sending to receiving site
• Answer technical questions from tech transfer perspective regarding Fill & Finish equipment
• Identify, lead and manage local and global capacity expansion projects to ensure a reliable supply for our patients
• Actively and self-reliantly, take decisions within capital projects and drive progress forward. Support strong collaboration within the projects and regularly report the status
• Provide process engineering support to front end design in Fill & Finish capital projects on Gene Therapy products
• Establishing global design standards for the Fill & Finish area in collaboration with internal stakeholders
• Scouting, evaluating, and implementing new technologies for Fill & Finish of gene therapy technologies in collaboration with R&D, and MS&T
• Actively contributing to the business success by continuous improvement and innovation initiatives
• 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
• Being a role model at expected behaviors and practices in accordance with our CSL values and CSL Guidelines of health, safety, and environment

Your Skills and Abilities:

You are a passionate technology stakeholder who leads programs and projects successfully by proactive, positive and self-responsible approach. You take decisions and drive progress forward.

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 (ideally experience in the area of Aseptic Filling and Engineering for Aseptic Fill & Finish Area)
• GMP experience and awareness of state-of-the-art industry practices and trends in the field
• Proven track record in managing projects, programs and manufacturing processes in a highly regulated environment as well as managing performance and delivering business value
• Exceptional interpersonal and collaboration skills
• Innovative thinker with strong business acumen who drives for results
• Ability to manage competing priorities and agendas
• Excellent stakeholder focus and collaborative mindset, ability to inspire others and at all times exemplifying CSL employee brand and values
• Attentive communication skills, understanding your counterpart, strong ability to build-up trustful and forward-thinking business relationships as well as keeping your stakeholders informed, using influencing & negotiation skills if appropriate
• Excellent written and spoken English language skills

This role is available for any of the CSL Behring Manufacturing sites across the globe – preferably based in Boston, US.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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 CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.