Scientist I/II (Formulation/Freeze Drying)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jun 10, 2021
Ref
R-132612
Required Education
Bachelors Degree
Position Type
Full time

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 Summary:

The prospective scientist 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.  The individual will provide scientific expertise to ensure studies are well thought out and have clear, measurable benefits.  Leads and drives elements of these activities as required.  
 

Major Responsibilities:

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
     

People Management:

  • 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
     

Other:

  • Drives safety compliance among colleagues in the laboratory
  • Produces high quality technical presentations for TD team members and other technical teams (e.g. MS&T)
     

Minimum Requirements:

  • Bachelor’s or master’s degree or PhD in Pharmaceutical sciences or related scientific field.
  • 8+ years with BS, 6+ years with MS or 0-2+ years with PhD.
  • Requires in-depth conceptual and practical expertise in drug product development especially large molecule (protein, nucleic acid) product development, typically with a strong focus on formulation development, process development and key analytical assays.
  • Strong knowledge and experience about freeze drying/lyophilization is a must. Physical characterization of large molecule formulation using high-end instrumentation (e.g. CD, DSC etc.) will be a plus. Knowledge about primary packaging will be a plus too.
  • 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.
  • Effective verbal & written communication skills in a cross functional environment.
  • Excellent project management skills.
  • Excellent presentation skills.