Downstream Bioprocess Scientist
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.
The Bioprocessing Scientist will work hands-on in a high-performing, cross-functional team with the goal of developing and transferring scalable processes from clients to Good Manufacturing Practice (GMP) for the manufacture of viral gene therapy products. Team member will be responsible developing and authoring experimental study plans and reports, executing experimental studies, analyzing data, supporting the execution of manufacturing activities (including Process Description and Block Flow documents) and providing additional support to other departments as required (Quality Assurance, Quality Control, Program Management) with minimal supervision.
Planning and performing tech transfer experiments in Process Development (PD) lab related to viral vector process development, optimization tech transfer and problem-solving; using stirred-tank bioreactors and chromatography skid up to pilot scale. May require moderate support of Senior scientist.
Scrutinizes processes for improvement and scalability, and utilizes background and expertise in upstream production, harvest, recovery, and chromatography and formulation technologies to establish and optimize new processes for incorporation into viral product manufacturing.
Responsible for compiling and analyzing data from Process Development, troubleshooting and historical processes, and summarizing in high-quality reports, supported with accurate and up to date records, including appropriate lab notebook annotations.
Designs and executes experiments with minimal supervision, including data analysis and communication. Interprets results and proposes next steps to manager.
Helps to create and revise task orders for contractual relationships and new client development.
Capable of achieving deliverables in a timely fashion, and clearly communicating results to clients and cross-functional teams.
Expected to evaluate and recommend new technologies to enhance efficiencies of processes and scale, where applicable.
Serve as project-lead for client-specific upstream process development and process tech transfer, from client to Process development group and from PD to Production group.
Ability to manage and prioritize several projects in parallel is key.
Expected to tackle complex problems where analysis of technical data requires an in-depth evaluation of various factors. Ensures schedules, and performance requirements are met.
BS degree in biosciences, engineering or related discipline plus 5 years of related bioprocess experience in an FDA-regulated environment; or MS degree and 2-4 years of experience.
Must have thorough knowledge of cGMP requirements and facilities
Hands-on expertise with scalable bio-production platforms with direct experience of bioreactors, depth filtration/clarification, ultrafiltration/diafiltration) and chromatography technologies
Must possess good mathematics, engineering, statistical analysis and good documentation skills.
Demonstrated skills in problem-solving and proposing solutions
Formal tech transfer experience in developing new processes, scaling processes, and transferring processes into operations is a must. Working knowledge of closed and single use systems highly desirable.
Demonstrated ability to prioritize projects and manage time including the ability to meet deadlines as set by supervisor
Must possess proven excellent written and oral communication skills including prior successful experiences in technical writing;
Independent work skills; strong work ethic; delegating skills; ability to perform in a team setting essential for this key position
Able to work in cross-functional project teams in a highly matrixed fast-paced clinical grade manufacturing organization.
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.