Scientist - Viral Vector Downstream Process Development

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.

A highly motivated experienced scientist in development and optimization of downstream processes for the production of viral vector and gene therapy products. The successful candidate will have experience with downstream processing techniques:  TFF, UF/DF, chromatographic separation methods using HPLC, FPLC, membrane capture, filtration, formulation, and ultracentrifugation.  The candidate will also be proficient in viral vector characterization assays:  DLS, SDS-PAGE, spectrophotometry, and infectious titer assays.  The candidate will assist both technical scientists and management in the design and execution of new or unique viral vector-based projects; assist with tech transfer of processes to manufacturing and design of investigation studies for Manufacturing Scientist and Technology (MSAT) and manufacturing team; be able to train and mentor other technical scientists and manufacturing personnel in the development and / or execution of developed process plans; analyze bioprocessing data to monitor, optimize, and determine limits of process performance.

Key responsibilities:

  • Responsible for successful development and execution of state-of-the-art manufacturing processes for cGMP manufacturing within the viral vector development matrix

  • Interact with new or existing viral vector and gene 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 viral vector process optimization and scale up, and troubleshooting of processes.

  • Understand downstream processing techniques:  chromatographic separation methods using FPLC and HPLC, TFF, UF/DF, filtration methods

  • Understand viral vector-based assays including, but not limited to, DLS, SDS-PAGE, infectious titer and viral particle determination (TCID50, hexon immunoassay, ddPCR)

  • Oversee the initial technical transfer of specific Process Development protocols to Viral Vector Therapy Manufacturing Teams

  • Present data and clearly communicate the results of process development studies with the clients

  • 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 SOPs, protocols, reports, and batch records

Key requirements:

  • PhD in Life Sciences with focus on biology or Bioengineering with advanced years of related manufacturing or process development experience in biotech industry experience; MS degree in Life Sciences field and expertise in manufacturing or process development experience in biotech industry.

  • Experience with chromatographic separation, filtration, and UF/DF techniques

  • Experience or knowledge of analytical methods and in process controls commonly used in manufacturing processes techniques

  • Self-directed and self-motivated; demonstrated ability to work both independently and also as a team member in a matrix environment;

  • 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

  • Exceptional oral and written English communication skills

  • Excellent computer software skills related to Microsoft office and data analysis;

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

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.

Reference: R27036