Senior Scientist (Analytical Chemistry)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Oct 10, 2020
Ref
R-119571
Required Education
Associate 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 leading/managing assay development of Separation Science within Analytical Development. The incumbent will serve as an expert on key technologies of analytical chemistry, manage HPLC/UPLC and GC laboratory, develop advanced analytical methods for release, in-process control, stability, and characterization of novel vaccine candidates and transfer to QC. As a group leader, this individual will lead a group of 4-5 scientists/associates and drive the development and qualification of analytical assays for release Tox and CTM as well.

Major Accountabilities:

Development Work:

  • Leads the development and execution of strategies, plans, and methods to enable product and process development, and method optimization, testing and transfers and improvements for Technical Development
  • Uses a data driven approach to drive development deliverables
  • Proactively identifies development and improvement opportunities, generates a supportive business case, and drives cross-functional teams to deliver those opportunities
  • Responsible for using scientific knowledge to lead site / global projects


Operations/Quality Support:
  • Serves as a primary interface between TD and Research, Operations, and represents TD in cross-functional forums to support vaccine development, manufacturing and QC.
  • Utilizes extensive knowledge and experience to provide technical leadership for production and characterization of drug substance and drug product, support manufacturing and QC.
  • Utilizes extensive knowledge and experience authoring and providing technical content for IND and BLA.
  • Uses scientific and statistical knowledge to provide leadership for 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 team members
  • Demonstrated leadership abilities through project leadership and mentoring.


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


Minimum Requirements:

• Postgraduate degree (preferably PH.D or MS) and extensive experience in analytical chemistry or related area.
• Minimum of 5 years' relevant experience with a Ph.D., minimum of 10 years of relevant experience with a Master's.

• Provides comprehensive advice on a wide range of issues within own discipline

• Demonstrated leadership abilities through people managing, project leadership and mentoring

• Demonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solving

• Experience in pharmaceutical development in one or more of various disciplines including (but not limited to) Analytical Chemistry, Biochemistry, etc. Extensive experience on HPLC, UPLC, SEC-MALS assay
development required. Previous experience on GC and CE preferred.