Lonza Biologics Porriño SLU
Scientist II, BioAssay Services
Lonza Biologics Porriño SLU, Houston, Texas, United States, 77246
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.
POSITION: Scientist II, BioAssay Services
JOB LOCATION :
14905 Kirby Dr, Houston, TX 77047 DUTIES: 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. MINIMUM 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. 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.
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14905 Kirby Dr, Houston, TX 77047 DUTIES: 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. MINIMUM 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. 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.
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