Principal Scientist in Plasma Product Development

vor 1 Woche

Bern, Schweiz CSL Behring Vollzeit

Within Plasma Product Development, we develop novel, high quality plasma-derived therapies that improve the health and well-being of our patients around the world. Our ability to innovate and deliver life-saving medicines for these individuals living with rare diseases and other unmet medical needs has earned us a reputation for always putting patients first. Our core business is to develop safe, innovative, and effective drugs using cutting edge technologies for manufacturing processes (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. We are striving for a caring and sensing network organization which lives a culture of trust and collaboration. Our smart people drive innovation through their expertise, passion and "getting it done" mentality. To achieve this goal, we have embraced new ways of working and thinking.

As Principal Scientist in Bioprocess Development Bern, Switzerland, you are part of global Plasma Product Development. The department Bioprocess Development is responsible to design products and manufacturing processes that consistently deliver the intended quality and performance. Activities encompass manufacturing process development for early to late-stage phases and for marketed products, the transfer of product and processes to commercial manufacturing sites and support of commercial process improvements.

Your major responsibilities in this position are the following:

- Process development and Technical Transfer of biologics for clinical development and market.
- Lead development of robust manufacturing processes for biologics, including process design, process characterization, scale-down and scale-up, validation and transfer to global commercial manufacturing sites.
- Plan and conduct process development experiments and work closely with laboratory employees, support risk assessments, and process performance qualification runs to generate data and support transfer and launch of plasma products.
- Coach and review the work of laboratory employees.
- Perform data analysis and write development summary reports.
- Representation of Bioprocess Development as SME in global CMC teams, functional representative in cross-functional teams and international governance meetings.
- Evaluation and implementation of new methods and technologies, scientific contributions (e.g. publications and conference talks).
- Contribution to the organizational development of Bioprocess Development.
- Comply with the relevant quality systems.

Your Qualification:

- Proven experience in process development, including design of down-scale models, process parameters definition and characterization (e.g. for new technologies), process validation and transfer as well as quality by design principles is desired.
- In depth knowledge and experience with chromatography in an industry setting (including different chromatography types, resin screening, scale-up and scale-down, column packing etc.), UF/DF, purification, filtration, mixing, virus inactivation and reduction, both conventional and single use platforms.
- Experience in early and late-stage process development and the commercial manufacture of drugs is preferred.
- Proven experience with Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drugs and manufacturing processes.
- In depth knowledge or experience in digital tools, ELN, data analytics and visualization software (JMP). Experience with programming or JMP scripting is an advantage.
- Good knowledge of FDA/ICH/EMA guidelines and cGMPs, phase-appropriate development strategies and global requirements for IND, NDA and BLA submissions (or their regional equivalents) is an advantage.
- Experience with IND/BLA/MAA writing and/or review is an advantage.
- Excellent scientific leadership skills and collaborative behaviors, with global/interdisciplinary thinking, proven organizational and planning abilities as well as excellent stakeholder management skills.
- Strong presentation skills and scientific/technical writing skills in English.

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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