Scientific Associate II (Process Development / Downstream Purification)
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 person in this role will support the TD drug substance and drug product process development and tech transfer for PH I clinical manufacture.Major Accountabilities:
- Partner with diverse team members across functions to independently develop, troubleshoot, scale up, and tech transfer 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 design and execute small scale experiments to characterize and define bioprocess steps.
- Generate test article material for Phase I clinical studies (GMP).
- 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.
- 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.
- Bachelor’s Degree in related scientific or engineering field with 3+ years related experience or Master’s Degree in related scientific field with 0-1+ 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