Principal Engineer, (MS&T) - Viral Pilot Plant
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Principle Scientist Manufacturing Sciences and Technology will be responsible to support development of a new Influenza platform with mRNA technology as well as the Viral Pilot Plant team at the Holly Springs facility. This role will be responsible for the MS&T support of the sa-mRNA drug substance and drug product process development; Phase 1 clinical manufacture through commercialization. In addition, this role will be responsible for protocol development in the VPP area, support of technical investigations and development of MS&T pilot scale studies.Major Accountabilities:
- Partner across functions to independently determine MS&T support model for development, troubleshooting, scale up, and tech transfer of the sa-mRNA process for PH 1 clinical manufacture.
- Solve complex problems using analytical thinking gained through formal education and/or previous roles.
- Both independently and collaboratively learn and support sa-mRNA process influencing commercial scale development.
- Support generation of test article material for Phase I clinical studies (GMP).
- Train on and then independently operate small scale and pilot scale bioprocess equipment including nanoparticle assembler, TFF, and NFF.
- Understand and interpret experimental data and results to support decisions, definition / knowledge, and tech transfer of sa-mRNA purification process.
- Understand and apply bioprocess scale-up principles and strategies.
- Prepare technology development study protocols and reports, BPRs, and SOPs in support of tech transfer and regulatory documents for multiple products.
- Communicate (presentations, write-up in technical documents, etc.) results to colleagues, project teams, management and external partners.
- Be accountable for developing own self to enhance contribution.
- Master’s Degree or higher in molecular biology or related scientific field with 7+ years related experience
- Knowledge and experience handling nucleic acids required
- Knowledge of aseptic technique required
- Knowledge of GMP manufacturing required
- Knowledge of bioprocess unit operations, especially in vitro nucleic acid synthesis, nanoparticle assembly, TFF and NFF filtration, and engineering scaling principles, is desired
- Ability to work with cross functional teams is required
- Strong communication skills, technical writing ability, and good attention to detail is required
- Must be a self-starter and able to work with minimal supervision