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.
For our Geleen site we are looking for a Scientist I to join our Research and Development team.
The Development Scientist, Bioassays Level 1 performs analytical support, assay development and optimization, assay qualification and validation for Cell and Gene Therapy products. This position is also responsible for writing Method SOPs and Forms. Responsible for writing protocols and reports for Assay Qualification and Assay Validation. Oversees training of QC Analysts on new assays and transferring these assays to QC. Interacts with clients in meetings specifically about Assay Tech Transfer, Qualification and Validation
- Expert in cell-based assays including, but not limited to, morphological assessment, cell proliferation, functional differentiation, cytotoxicity, detection of marker expression (ICC), Flow Cytometry, qPCR, ddPCR and ELISAs
- Responsible for performing Assay Development and Optimization and evaluating methods received from client for equipment and materials gaps prior to starting transfer activities.
- Writes Assay Qualification Protocols and Reports according to Lonza standards and SOPs.
- Writes Assay Validation Protocols and Reports according to Lonza standards and SOPs.
- 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 SME on specific assays. May serve in consultation role on difficult Laboratory Investigations in QC as needed.
- 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)
- Performs other duties as assigned
- PhD in Life Sciences with focus on Biology or Bioengineering with related work experience; or MS degree in Life Sciences field with significant related work experience, or BS degree with a high level of related work experience in analytical development, QC or process development experience in biotech industry.
- Experience or knowledge of analytical methods and in process controls commonly used in manufacturing processes such as cell count viability, flow cytometry, and molecular biology techniques
- Self-directed and self-motivated; demonstrated ability to work both independently and also as a team member in a matrix environment; maintains a positive approach to setbacks and challenges; champions new ideas and initiatives; brings out and utilizes others' creativity to improve team performance
- Client oriented: establishes effective and responsive relationships with all clients; able to translate client projects into a feasible process design; known to ensure value is always delivered to the client
- Exceptional oral and written English communication skills
- Excellent computer software skills related to Microsoft office and data analysis; capable of keeping professional, accurate and timely records of all essential activities; able to manage multiple projects; excellent time management skills
- Biotech Industry experience and Cell and Gene Therapy experience is highly preferred
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.