Scientist – Upstream Process Development
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.
The Process Development (PD) 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 Practices (GMP) for the manufacture of viral gene therapy products. Team member will be responsible for designing 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 (QA), Quality Control (QC), Program Management(PM)). The candidate is expected to evaluate and recommend new technologies to enhance efficiencies of processes and scale.
- Works independently in planning, performing, analyzing, summarizing, reporting and presenting technology transfer experiments in the PD lab related to Upstream Process development, optimization, tech transfer and troubleshooting for Adeno-Associated Viruses (AAV), Adenovirus Type 5 (Ad5) and Lentiviral Vectors (LVV); using Stirred Tank (STR) or rocking motion bioreactors up to pilot scale and scalable adherent systems; clarification, Tangential Flow Filtration (TFF) and other unit operations up to production of column load material
- Critically analyzes processes for improvement and scale-up, and utilizes knowledge and expertise in upstream production, harvest and recovery technologies to establish and optimize new processes for incorporation into viral product manufacturing.
- Responsible for compiling and analyzing data from PD, troubleshooting processes, and summarizing data in high-quality reports, supported with accurate and up to date records, including appropriate lab notebook annotations. Provides PD support to ongoing manufacturing activities as needed (run monitoring, control cultures, etc).
- Independently designs and executes experiments, including data analysis and communication. Interprets results and proposes next steps. Experienced in Design of Experiment (DoE) and statistical analysis software.
- 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.
- PhD with intermediate years of experience or Master’s Degree and advanced years of experience in bioprocessing development in an FDA-regulated environment.
- Preference to thorough knowledge of current Good Manufacturing Practices (cGMP) requirements and facilities.
- Hands-on expertise with scalable bio-production platforms and direct experience of upstream technologies (STR/WAVE, depth filtration/clarification, ultrafiltration/diafiltration).
- Demonstrated skills in problem-solving and proposing solutions.
- Hands on experience in process development, process scale up and tech transfer 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.
- Must possess proven excellent written and oral communication skills including experience with technical writing .
- Independent work skills; strong work ethic; delegating skills; ability to perform in a team setting is essential for this lead position.
- Comfortable working 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.