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 Sr. Scientist, Plasma Product Development (PPD) Technical Operations-II (TO-II) is responsible for leading and executing PPD R&D process improvement activities in support of local manufacturing operations related to CSL Behring’s commercially licensed products and intermediates. Support activities can also extend out to other CSL Behring global manufacturing sites producing plasma products or intermediates. The scope of the role includes driving process improvements (e.g., yield, robustness, and cost), collaborating with the data analytics team to troubleshoot process challenges and identify improvement opportunities, and providing technical leadership on projects.
Follows methodical process optimization and scale-up/down approaches and trains Scientist I/Scientist II staff as applicable. Implements process changes with cGMP compliance. The incumbent is responsible for ensuring that studies are executed according to the site priorities using representative and qualified scale-down and pilot scale models per existing policies. The incumbent will display team work and global perspective while collaborating with other global PPD R&D groups in alignment with CSL Behring’s PPD strategic objectives.
The Sr. Scientist, PPD TO-II will be expected to keep abreast of new technologies and approaches and strategically employs these into the improvement and optimization of protein separation/purification processes in order to increase safety, compliance, and/or commercial profitability.
- This position reports to: Manager, Technical Operations, Kankakee.
- 0-5 individual contributors may report into the incumbent
Main Responsibilities and Accountabilities
1. As a Sr. Scientist, TO II, s/he focuses on medium to long term deliverables. Areas of responsibilities include:
- Building project plans and defining problem scope/problem statement.
- Ensuring agreed targets for quality, timelines, costs, and user requirements are met.
- Executing project plans with clear goals and adherence to timelines/resource constraints.
- Effective partnership with Manufacturing, PD, BTT, TOI, and Data Analytics functions to identify feasible process improvement opportunities.
- Leading and executing protocol driven process improvement studies through effective utilization of DoE methodology.
- Scale up from bench to pilot scale; scale down from commercial to bench/pilot scales.
- Technical transfer to pilot scale and commercial scale.
- Define process characterization plans and implement support strategy for validation activities.
- Aligning functional outputs with developments in Regulatory and Quality guidance (e.g. ICH Q8/9/10/11 and FDA/EMEA process validation guidance).
- Implementing best practices in bioprocess support (e.g. application of DoE, QbD, new technologies).
- Full documentation of Process Improvement activities according to appropriate Quality standards and in support of IP.
- Ensuring data integrity and scientific rigor in TO experiments
- Support of regulatory filings and regulatory audits as appropriate.
2. Maintains awareness of cGXPs, good scientific practices, follow and promote lab and office safety.
3. Provides effective and transparent communications to customers and stakeholders such as but not limited to, Quality, Operations, and Global and local R&D and site senior management.
Position Qualifications and Experience Requirements
Combination of academic qualification and appropriate* experience in biotech industry.
Bachelors of Science with 8+ years relevant experience
Or Masters of Science with 6+ years relevant experience
Or PhD with 3+ years relevant experience
*Appropriate: A combination of protein purification, plasma fractionation or bioprocess R&D manufacturing technical support experience.
Essential Skills, Knowledge and Experience
- Technical knowledge of product life cycle management, process change management, biological licensure, and plant operations,
- Demonstrated implementing innovative solutions,
- Experience with project management,
- Plasma fractionation experience is highly preferred. In-depth knowledge and hands-on experience with protein separation/purification process optimization and scale-up/down are required.
- Proven knowledge or expertise of DoE/statistical analysis.
- Business Acumen
- Decision Quality
- Problem Solving
Energy and Drive
- Drive for Results
Organizational Positioning Skills
- Organizational Agility
- Presentation Skills
- Written Communications
- Managerial Courage
- Managing and Measuring Work
- Priority Setting
- Time Management
- Results driven
Personal and Interpersonal Skills
- Customer Focus
- Ethics and Values
- Integrity and Trust
- Motivating Others
- Peer Relationships
- Team Player