Scientist II, BioAssay Services

Lonza•Houston, TX

About The Position

Today, Lonza is a global leader in life sciences operating across five 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. Lonza is currently seeking an experienced Scientist II, BioAssay Services to join their team in Houston, TX.

Requirements

Requires a Master’s degree, or foreign equivalent degree, in Medical Sciences or Biochemistry and Molecular Biology and 2 Years of experience in the job offered, or 2 Years of experience in a related occupation developing and executing state-of-the-art manufacturing processes for Current Good Manufacturing Practices (cGMP) within the Cell Therapy Development matrix with minimal support from development manager; utilizing experience with cellular, biochemical and molecular techniques including cell culture, nucleic acid extraction, real time qPCR/RT-PCR, ddPCR, flow cytometry, microscopy, ELISA, spectrophotometric, and fluorometric cell-based potency assays.

Responsibilities

Design analytical methodology for the characterization of Cell and Gene Therapies.
Execute analytical testing to characterize Cell and Gene Therapy drug products/substances.
Validate analytical methodology for the characterization and release of Cell and Gene Therapies.
Transfer analytical methodologies to the quality control laboratory and train quality control analysts.
Lead client discussion and drive project direction.
Manage project timelines and delivery.
Lead a project team in a matrix organization to deliver projects on-time and in-full.
Develop junior scientists analytical capability through direct on-the-job training and mentorship.
Present and explain complex scientific concepts and data to audiences of varying levels of scientific competency.
Identify and manage potential new business through client management, relationship building, and problem solving.
Develop and execute studies relevant to assays required for development and execution of Current Good Manufacturing Practice regulations (cGMP) manufacturing of Cell and Gene Therapy Products within the development matrix.
Interact with new and 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.
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 and monitoring assays into such processes.
Provide technical and scientific leadership to other team members which includes, providing assistance to management in the design of new, unique or existing protocols.
Support and lead the discussions around definition of scope of development work and resource planning.
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, train, assist in writing and revising technical documents including laboratory Standard Operating Procedures (SOPs), protocols, reports and batch records.
Develop and execute state-of-the-art manufacturing processes for current Good Manufacturing Practices (cGMP) within the Cell Therapy Development matrix with minimal support from development manager.
Utilize experience with cellular, biochemical and molecular techniques including cell culture, nucleic acid extraction, real time qPCR/RT-PCR, ddPCR, flow cytometry, microscopy, ELISA, spectrophotometric, and fluorometric cell-based potency assays.
Oversee One(1) Scientist I.