Associate Scientist I/II - Analytical Separation Science

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Aug 27, 2020
Ref
R-120646
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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 analyst hired for this position will support potency testing of analytical characterization of bulk samples, strain surveillance, and process development. The potency testing is an HPLC method after sample preparation.

Major Accountabilities

Supportive Work
  • Analytical assay execution in support of vaccine process and product development programs, e.g. HPLC/UPLC, gel electrophoresis, ELISA etc.
  • Data collection and reporting with knowledge of GLP/GMP environments.
  • Work closely with the Separation, Biochemistry, and Molecular and Cellular Biology groups within TD-Analytical
  • Perform tasks under limited supervision.
  • Provide support on reviewing documentation in notebooks and reviewing data in LIMS for specific lab based processes that the employee is trained on.
  • Able to work under tight deadlines.
  • Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards.
  • Partner with diverse team members from various functions, countries and members at various levels in the organization.
  • Functions effectively as core team member.
  • Interface with electronic business systems (e.g, LIMS, SAP, EDMS)


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


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


Minimum Requirements
  • Bachelor's Degree in related scientific field
  • 2+ years of related experience with hands on experience on HPLC/UPLC, and electrophoresis
  • Requires in-depth conceptual and practical expertise in High Performance Liquid Chromatography
  • Experience with analysis of proteins and/or RNA is highly desired
  • Experience with CE, and/or cell culture is a plus
  • Experience in biopharmaceutical analytics is desirable
  • Demonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solving
  • 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
  • Attention to detail
  • Proactively owns and drives assigned tasks to completion
  • Ability to present solutions to complex and strategic issues
  • Evidence of commercial awareness in technical strategies
  • Excellent customer focus with demonstrated management of customer expectations