Scientist II (Cell and Molecular Analytics)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Sep 16, 2021
Ref
R-134869
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 will be responsible for the design, execution, and qualification of analytical method development activities utilizing Cell and Molecular Biology techniques. This work will support analyses of APIs, DP, process impurities and stability by-products across multiple platforms.  The individual will provide scientific expertise for process and product development projects through TD into Operations. Supports projects that will drive future growth through process improvements and uses scientific knowledge to ensure studies are well designed, executed, documented and have clear, measurable benefits. Leads and drives elements of these activities as required.

Major Responsibilities:

Development Work:

  • Contribute to the development and qualification of Molecular Biology analytical assays to support process and product development, including characterization and quantitation analyses of both in-process samples and final products
  • Evaluate novel Molecular Biology analytical technologies, propose new assays or improvements to current methods
  • Work closely with the Separation, Biochemistry and Mass Spec 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, characterization reports, and/or 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 and establishes work processes

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 8-10+ years, MS with 5-8+ years, or PhD with 2-4+ years experience is required in relevant field.

  • Requires in-depth conceptual and practical expertise in the development of Molecular Biology assays for biologics or vaccine molecules  

  • Extensive experience in working with DNA and RNA required

  • Experience in qPCR, RT-PCR and digital PCR required

  • Experience in next-generation sequencing (NGS) technologies is advantageous

  • Experience in biopharmaceutical analytical development and method qualification is desirable

  • 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; effective presentation skills

  • Attention to detail and 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