United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The candidate for this role will be experienced in development and optimization of cell culture processes for the production of cell therapy products. The successful candidate should have experience in pluripotent stem cell expansion and differentiation, primary cell isolation techniques, in vitro culture of primary cells derived from human tissue, the culture of adherent and suspension cell lines, downstream and fill/finish processing. She/he should be able to assist both technical scientists and management in the design and execution of new or unique cell-based projects; be able to assist with tech transfer of processes to manufacturing; be able to train and mentor other technical scientists and manufacturing personnel in the development and / or execution of developed process plans; analyze processing data to monitor, optimize and determine limits of process performance.
- Responsible for successful development and execution of state-of-the-art manufacturing processes for Current Good Manufacturing Practices (cGMP) within the Cell Therapy Development matrix
- Interact with new or existing Cell Therapy clients to document and transfer new processes to Lonza sites and communicate and present the work in meetings
- Contribute and support scientific or engineering expertise toward the design and development of new process ideas that support client product concepts
- Design and review of experiments of cell process optimization, scale up and cryopreservation, trouble shoot the problems.
- Understanding cell-based assays including, but not limited to, morphological assessment, cell proliferation, functional differentiation, cytotoxicity, detection of marker expression (ICC), Flow Cytometry, Quantitative Polymerase Chain Reaction (qPCR) and ELISAs
- Provide technical and scientific leadership to other team members. This includes providing assistance to management in the process design of new, unique or existing protocols
- Oversee the initial technical training of specific Process Development protocols to Cell Therapy Manufacturing Teams
- Establish and maintain a good working relationship within the operations department and other departments such as Research and Technology (R&T), Quality Control (QC), Quality Assurance (QA) and Project Management (PM).
- Lead, review and/or train/assist in writing and revising technical documents including laboratory Standard Operating Procedures (SOPs), protocols, reports and batch records
- Support Research and Technology (R&T) projects by providing constructive technical feedback and improving new processes as they are being transferred into Cell Therapy Development prior to offering to clients
- Provides feedback to management and maintains an amicable and compliant work environment and corporate culture. Works on problems where analysis of situations or data requires an in-depth evaluation of numerous factors. Ensures schedules and performance requirements are met.
- PhD in Life Sciences with focus on Biology or Bioengineering with a working knowledge related to manufacturing or process development experience in biotech industry or MS degree in Life Sciences field with a significant amount of experience related to manufacturing or process development experience in biotech industry.
- Experience with variety of cell culture systems and optimization of cell expansion and differentiation process.
- Experience with the development and transferring of 2D cell culture systems and /or 3D bioreactor processes to Current Good Manufacturing Practices (cGMP).
- Experience or knowledge of analytical methods and in process controls commonly used in manufacturing processes such as cell count viability, flow cytometry, and molecular biology techniques
- Experience with development of bioreactor protocols and scale up studies for mammalian cells or stem cells is highly desirable
- Self-directed and self-motivated; demonstrated ability to work both independently and as a team member in a matrix environment; maintains a positive approach to setbacks and challenges; champions new ideas and initiatives; brings out and utilizes others' creativity to improve team performance
- Client oriented: establishes effective and responsive relationships with all clients; able to translate client projects into a feasible process design; known to ensure value is always delivered to the client
- Excellent computer software skills related to Microsoft office and data analysis; capable of keeping professional, accurate and timely records of all essential activities; able to manage multiple projects; excellent time management skills
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.