Scientist II, Drug Product Development

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jan 28, 2021
Ref
R-127824
Required Education
Masters Degree/MBA
Position Type
Full time
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 and guidance in the application of relevant technology platform to research and product development activities.

Responsible for Drug Product Development projects , independently responsible for the conception, design, implementation of studies, and interpretation of scientific data to support TD projects.

Major Accountabilities:
  • Ensures high quality application of technology platform in order to support designated project objectives.
  • Contributes to the planning, performance, evaluation and reporting of scientific experiments at the highest levels of scientific integrity.
  • Works together with and provide expertise to other team members in order to achieve specified research project objectives within defined time parameters.
  • Supports the development and execution of strategies, plans, processes and methods to enable product and process development, process transfers and improvements for TD.
  • Author study protocols, technical reports and SOPs
  • 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 leads small projects and establishes work processes
  • Responsible for using scientific knowledge to support site / global projects
  • Serves as interface between TD and Operations, and represents TD department in cross-functional 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


    Minimum Qualifications:
    • Postgraduate degree (preferably MSc or PhD) and / or experience in relevant discipline.
    • Minimum of 3 years' relevant industry experience and / or equivalent experience in a relevant academic environment.
    • Requires in-depth conceptual and practical expertise in large molecule formulation, freeze drying, and key analytical assays
    • Knowledge about physical characterization of large molecule formulation using high-end instrumentation (e.g. CD, DSC etc.)
    • Requires in-depth conceptual and practical expertise in formulation development, process development and primary packaging
    • Experience in biopharmaceutical development in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Drug Product
    • Effective delivery of objectives in a complex matrix environment
    • Effective verbal & written communication skills in a cross functional environment