CSL Plasma
Scientist II, Drug Product Development
At a glance
Location: US-NC-Holly Springs Map
Posted: 04/11/2021
Closing: 05/10/2021
Degree: 4 Year Degree
Type: Full-Time
Experience: Not Specified
CSL Plasma
Job description
About CSL

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!


Job Description



Job Purpose:

Provides scientific expertise for the design, planning, and execution of drug product development projects.  

Supports drug product development from early phase to late phase through formulation and process improvements. 

Provides scientific expertise to ensure studies are well thought out and have clear, measurable benefits. 

Leads and drives elements of these activities as required.  



Major Accountabilities:

Development Work:

-Applies demonstrated background in formulation development, lyophilization, and delivery device design and selection for development of protein and nucleic acid based vaccine drug products.

-Oversees execution of all laboratory development studies, including hands on experimentation, for one or more drug product development projects.

-Supports the development and execution of strategies, plans, processes and methods to enable drug product and process development and process transfers.

-Executes multiple key Drug Product Development projects under limited direction, independently responsible for the conception, design, implementation of studies, and interpretation of scientific data to support TD projects.

-Uses a data driven approach for technical decision-making including risk assessment and mitigation.

-Author tactical technical documentation including study protocols and technical reports.

-Author strategic project documentation including process and product development plans.

-Proactively identifies development and improvement opportunities for new and legacy products.

-Interaction and assist with assessment of technical capabilities of key external partners and oversee 3rd party labs.

-Functions effectively as core team member on multiple concurrent projects and may lead major drug product development project.

Operations/Quality Support:

-Serves as interface between TD and Operations, and represents TD department in cross-functional technical transfer forums to support manufacturing and QC.

-Utilizes knowledge and experience with drug product process to provide technical support for production of drug product in GMP manufacturing.

-Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work.

Leadership:  

-Provides guidance and mentorship to less experienced colleagues and acts as a technical advisor.

-May have a small number of direct or dotted line reports depending on project.

-Drives safety compliance among colleagues in the laboratory.

-Produces high quality technical presentations for TD team members and other technical teams.

Minimum Qualifications:

  • Bachelor’s degree in Pharmaceutical sciences or related scientific field.

  • Master’s Degree or PhD preferred.

  • Minimum of 8+ years of relevant experience with BS, 6+ years with MS or 2+ years with PhD required.

  • Requires in-depth conceptual and practical expertise in drug product development especially large molecule (protein, nucleic acid) product development.

  • Strong focus on formulation development, process development, and key analytical assays.

  • Knowledge about freeze-drying and physical characterization of large molecule formulation using high-end instrumentation (e.g. CD, DSC etc.) preferred.

  • Knowledge about primary packaging preferred.

  • Provides in-depth technical advice on issues within own discipline

  • Experience in biopharmaceutical development in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification, Drug Product preferred.

  • Effective delivery of objectives in a complex matrix environment

  • Ability to deal with rapid change

  • Effective verbal & written communication skills in a cross functional environment

  • Strong Attention to detail

  • Excellent project management skills

  • Ability to assigned tasks and drive results within projects

  • Proactively develops solutions to complex and strategic issues

  • Develops effective contingency plans

  • Good commercial awareness with evidenced application to technical strategies

  • Excellent customer focus with demonstrated management of customer expectations - anticipating customer needs

Scientist II, Drug Product Development