Senior Scientist - Process Development Downstream

United States, Houston (Texas)

Today, Lonza is a global leader in life sciences operating across three continents. 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 senior level process scientist with diverse experiences in biological processes. The candidate must have biopharmaceutical industry experience with developing, optimizing, and characterizing downstream processes including various chromatography methods. The successful candidate will participate in all facets of downstream process development for a wide array of viral vectors, including adeno-associated virus (AAV). Develop and troubleshoot scalable downstream processes for viral vectors. Support the technical transfer of processes to the manufacturing team. She/he should be able to assist both technical scientists and management in the design and execution of new or unique viral vector-based projects; be able to assist with tech transfer of processes to manufacturing and design of investigation studies for Manufacturing Sciences 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. She/he should be able to present data and clearly communicate the results of process development studies with the clients.

Key responsibilities:

  • Responsible for successful development and execution of state-of-the-art manufacturing processes for cGMP manufacturing of viral vector products within the Development matrix.
  • Interact with new or existing Cell and Gene Therapy clients to document and transfer new processes to Lonza sites and communicate and present the work in internal and client meetings.
  • Lead 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 process optimization, scale up and cryopreservation, trouble shoot the problems.
  • Understand analytical methods relevant to viral vector manufacturing and implementation of appropriate in process control or monitoring assays into the process.
  • Provide technical and scientific leadership to other team members. This includes providing assistance to management in the design of new, unique or existing protocols.
  • Oversee the initial technical training of specific Process protocols to the Manufacturing Teams.
  • Support or lead the discussions around definition of scope of development work and resource planning.
  • Lead project team in the development and supervise people.
  • Establish and maintain a good working relationship within the operations department and other departments such as Research and Development (R&D), 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.
  • Support Research and Development (R&D) projects including platform development by providing constructive technical feedback and improving new processes as they are being transferred into Cell and Gene Therapy Development prior to offering to clients.

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.
  • Demonstrated downstream process development experience of biological molecules, such as viral vectors, therapeutic recombinant proteins, monoclonal antibodies or vaccines for biopharmaceutical applications is required.
  • A thorough knowledge, and understanding of downstream process of biologics including various chromatography methods are required.
  • Hands-on experience of chromatographic principles and systems:  HPLC, FPLC
  • Hands-on experience with the operation and development of TFF, UF/DF, and filtration:  Repligen, SciLog
  • Working knowledge and skills for viral vector or vaccine purification is a plus.
  • Ability to plan, organize, problem solve (troubleshoot), design experiments, prioritize, work efficiently independently and in a team under tight timelines.
  • Experience or knowledge of analytical methods and in process controls commonly used in viral vector manufacturing.
  • Self-directed and self-motivated; demonstrated ability to work both independently and also 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.
  • Exceptional oral and written English communication skills.
  • 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.

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: R31367