Scientist II (TD Purification)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 13, 2020
Ref
R-123812
Required Education
Bachelors Degree
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 Summary

The individual is responsible for utilizing scientific expertise to lead commercial support and development projects through TD into Operations and provide ongoing technical support to Operations and Quality. Responsible for projects that will drive future growth through process improvements. Uses scientific knowledge to ensure studies are well thought out and have clear, measurable benefits. Leads and drives elements of these activities as required.

Major Accountabilities
  • Leads the development and execution of strategies, plans, processes and methods to enable influenza vaccine product and process development, and process transfers for TD
  • Uses critical thinking skills along with a data driven and risk-based approach to solve complex problems and progress development deliverables
  • Proactively identifies development and improvement opportunities, generates a supportive business case, and collaborates with cross-functional teams to deliver those opportunities
  • Responsible for using scientific knowledge to support site / global projects
  • Serves as an interface between TD and MS&T/Ops, and represents TD department in cross-functional forums to support manufacturing.
  • Utilizes extensive knowledge and experience with biopharmaceutical processes (i.e. cell culture, purification) to provide technical leadership for troubleshooting production issues for drug substance and drug product.
  • Utilizes extensive knowledge and experience authoring and providing technical content for development, tech transfer, and regulatory submissions.
  • Uses scientific and statistical knowledge to provide leadership for product, process, and testing related investigations that require development work.
  • Provides guidance and mentorship to less experienced colleagues and acts as a technical advisor
  • Demonstrated leadership abilities through project leadership and mentoring.
  • Completes individual training and maintains a state of compliance
  • Adheres to all safety requirements
  • Supports communication/updates as required


Minimum Requirements

Education

Bachelor's Degree in related scientific or engineering field with 8+ years related experience or Master's Degree in related scientific field or engineering field with 6+ years related experience or PhD in related scientific or engineering field with 1+ years related experience.

Experience
  • Knowledge/experience in protein biochemistry and separation sciences
  • Knowledge/experience specific to downstream/purification process development for tech transfer and implementation in a GMP environment
  • In depth knowledge of bioprocess unit operations (e.g. bioreactors, chromatography, centrifugation, precipitation, TFF and NFF filtration) and engineering scaling principles
  • Tech Transfer experience preferred
  • Vaccine development experience preferred
  • Experience with GE AKTA chromatography systems/Unicorn software and lab/pilot scale TFF systems required
  • Demonstrated knowledge of / expertise with analytical methods (e.g. SDS PAGE, Western Blot, HPLC, ELISA) is preferred
  • Experience in application of Design of Experiments and other statistical techniques
  • Tech transfer experience is preferred
  • Must be able to effectively partner with diverse team members from various functions, multiple countries and members at various levels in organization.
  • Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
  • Strong communication skills, technical writing ability, and attention to detail
  • Leadership experience and directing others