Senior Lead Fill & Finish Gene Therapy
- Employer
- CSL Behring
- Location
- Massachusetts
- Start date
- Mar 4, 2023
View more
- Discipline
- Science/R&D, Biotherapeutics, Genetics
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
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 new gene therapies to patients. As 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 RoleChampion 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
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’s important and so are you. Learn more about how we care 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 CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!
Company
As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research.
CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential.
CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries.
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!
Stock Symbol: CSL
Stock Exchange: Australian Securities Exchange
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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