Senior Scientist, BioAssay Services
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 process/analytical scientist with diverse experiences in development, optimization, qualification, and validation of analytical methods. The candidate must have biopharmaceutical industry experience with a wide range of assays including HPLC, ELISA, real-time PCR, cell-based infectious titer, potency assays and other general cell-based assays. Develop and troubleshoot robust and reproducible assays to support development of manufacturing process for cell and gene therapy applications. Support the technical transfer of analytical methods to the quality control (QC) team. Analyze bioprocessing data to monitor, optimize and determine limits of assay performance. She/he should be able to present data and clearly communicate the results of assay development studies with the clients.
- Responsible for successful development and execution of studies relevant to assays required for development and execution of current Good Manufacturing Practices (cGMP) manufacturing of cell and gene therapy products within the Development matrix
- Interact with new or existing Cell and Gene Therapy clients to document and transfer new protocols and procedures to Lonza sites and communicate and present the work in internal and client meetings
- Lead and support scientific expertise toward the design and development of new ideas and protocols that support client product concepts
- Design and review of experiments of assay optimization, qualification, validation, and trouble shoot the problems.
- Understand development of processes for manufacturing of cell and gene therapy products and implementation of appropriate in process control or monitoring assays into such processes
- 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 protocols to the QC 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
- Establishes the analytical methods based on standard cell and gene therapy development guidelines and works on designing the methods where analysis of situations or data requires a broad knowledge of related technology and consideration of manufacturing process, analytical methods and in process controls.
- Exercises judgment on current state-of-the-art procedures and practices to determine appropriate action. Relies on guidelines related to cGMP, god documentation practices, and the associated and appropriate regulatory requirements in development / optimization / qualification / validation of new assays.
- PhD in Life Sciences with focus on biology or Bioengineering with intermediate years of related experience; MS degree in Life Sciences field with advanced years; BS degree with extensive years of related manufacturing or process development experience in biotech industry.
- Experience with variety of cell culture systems and optimization of cell expansion and differentiation process.
- Experience and knowledge of analytical methods and in process controls commonly used in manufacturing processes such as cell count viability, flow cytometry, and molecular biology techniques.
- Demonstrated knowledge on antibody –based methodologies including, but not limited to, HPLC, immunocytochemistry, immunofluorescence, FACS analysis and ELISA.
- Experience with nucleic acid and proteins sample preparation/purification.
- Experience with optimization and qualification of quantitative experimental design and statistical methods.
- Experience with development of bioreactor protocols and scale up studies for mammalian cells and/or analytical method development for qualification and validation is highly desirable.
- 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 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.
- Computer software skills including Microsoft Office, TrackWise, DMS, ERP system; accurate record keeping; ability to manage multiple projects; time management skills.
- Diplomacy; negotiation skills; written and oral communication skills; independent work skills; strong work ethic.
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.