Scientist I (Separations)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jul 17, 2021
Ref
R-134907
Required Education
Doctorate/PHD/MD
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 Purpose:

The prospective Scientist I will be responsible for the development, characterization, and qualification of analytical separation methods for large molecules including nucleic acid and protein. The scope will include analyses of APIs, DP, process impurities, stability by-products, and raw materials across multiple platforms.  The individual will provide scientific expertise for process and product development projects through TD into Operations.  

Major Responsibilities:

Development Work:

  • Develop, optimize, characterize and qualify of analytical methods such as HPLC, UPLC, and CE to support process and product development.
  • Utilize multiple modes of detection including UV, fluorescence, ELSD, and CAD.
  • Work closely with the Mass Spectrometry, Biochemistry, and Molecular/Cellular Biology groups within TD-Analytical, as well as provide technical expertise in support of analytical methods being executed within the process development groups
  • Author study protocols, development and characterization reports, as well as scientific manuscripts for external publication
  • Use a data driven approach to progress development deliverables
  • Present results at internal and external meetings
  • Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards
  • Support the development and execution of strategies, plans, processes and methods to enable product and process development, and method and process transfers and improvements for TD 
  • Proactively identify development and improvement opportunities
  • Functions effectively as core team member on multiple concurrent projects and leads small projects

Operations/Quality Support:

  • 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 analytical techniques used in biopharmaceutical (i.e., vaccines) process development and 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
  • Generates a supportive business case, and supports cross-functional teams to deliver those opportunities

People Management:

  • Provides guidance to new team members, interns and students and acts as a resource for colleagues with less experience

Other:

  • Completes individual training and maintains a state of compliance
  • Adheres to all safety requirements
  • Supports communication/updates as required

Minimum Requirements:
  • B.S., Master’s Degree or PhD in related scientific field
  • B.S. and 5+ years; M.S. and 3+ years, or PhD and 0-2+ years experience required; 3-5+ years experience preferred with advanced degree.
  • Requires in-depth conceptual and practical expertise in analytical separation methodologies including HPLC, UPLC, and CE  
  • Experience with Empower is highly desired
  • Previous experience in working with RNA is highly desired
  • Experience in biopharmaceutical analytical development is desirable
  • Effective delivery of objectives in a complex matrix environment and ability to deal with rapid change
  • Effective verbal & written communication skills in a cross functional environment with great attention to detail
  • Evidence of commercial awareness in technical strategies
  • Excellent customer focus with demonstrated management of customer expectations
  • Effective presentation skills