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.
Development Scientist, Bioassays performs analytical support, assay development and optimization, and assay qualification. Responsible for writing Methods, Standard Operating Procedures (SOPs) and Forms. Responsible for writing protocols and reports for Assay Qualification and Assay Validation. Oversees training of Quality Control (QC) Analysts on new assays and transferring these assays to QC. Interacts with clients in meetings specifically about Assay Tech Transfer, Qualification and Validation.
- Writes Assay Qualification Protocols and Reports according to Lonza standards and SOPs.
- Writes Assay Validation Protocols and Reports according to Lonza standards and SOPs.
- Responsible for performing Assay Development and Optimization and evaluating methods received from client for equipment and materials gaps prior to starting transfer activities.
- May perform assays in support of Development process work.
- Writes Method SOPs and Forms. Reports test results, maintains raw data, and accurate laboratory records in accordance with applicable SOPs.
- Interacts with clients in Joint Project Team meetings regarding method development, optimization, qualification, validation and technical challenges.
- Trains QC Analysts on new methods during Assay Tech Transfer activities. Also interacts with QC on equipment platform alignment and assay qualification/validation strategies.
- Serve as Subject Matter Expect (SME) on specific assays. May serve in consultation role on difficult Laboratory Investigations in QC as needed.
- Performs other duties as assigned.
- Master’s Degree in Biological Sciences, such as Cell Biology, Biochemistry, Molecular Biology with advanced years of experience in a scientific laboratory OR PhD in Biological Sciences with intermediate years of experience.
- Preference to familiarity with a (Good Manufacturing Practices) GMP environment.
- Prior experience with analytical methods such as Enzyme-Linked Immunosorbent Assay (ELISA), real-time Polymerase Chain Reaction (PCR), cell-based infectious titer, potency assays and other general cell-based assays.
- Excellent scientific writing skills.
- Seeks to build upon a solid understanding of cGMP principles and assay qualification principles.
- Solid knowledge of analytical method validation principles and applications.
- Understanding of basic laboratory equipment and aseptic technique.
- Proficient in the use of spreadsheets, databases, and word processing software.
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.