Scientist I (Cell and Molecular Analytics)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Dec 22, 2020
Ref
R-127827
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

Responsibilities:
  • Review and preparation of new and revised Standard Operating Procedures associated with the functions of the Analytical Testing for support of early phase Clinical Trial Material (CTM)
  • As required, provide analytical assay execution in support of vaccine process and product development programs, e.g. RNA activity, LNP potency, qPCR for process development or process improvements.
  • Perform review of analytical documents, checking for compliance with Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)
  • Oversee and coordinate analytical laboratory equipment qualification documents
  • Oversees and advises on the development of Standard Operating Procedures, Guidelines and other tools to support early phase CTM testing support.
  • Supports the quality and compliance training program; collaborates with operations management to ensure staff training is current as required by their role.
  • Works with TD-QA team as liaison to ensure all quality attributes are in place to support GLP testing and close gaps related to GLP or GxP lab requirements.
  • Evaluates procedures and processes affecting quality and proposes process improvements when applicable.
  • Experienced and very knowledgeable of FDA, EMA, and other regulatory regulations.
  • Experienced in managing concurrent complex projects/programs (e.g. process improvement initiatives for lab).
  • Functions effectively as core team member on multiple concurrent projects and leads small projects and establishes work processes


Qualifications:
  • 5+ years with BS, 3+ years with MS or 0 years with PhD
  • Experience with Cell culture and familiarity with instruments associated with cell-based assays required.
  • Experience with analysis of RNA is highly desired for support of Analytical Lab Development and assay improvements.
  • Knowledgeable in R&D compliant quality systems, experience with FDA, EMA, and other regulatory regulations desired.
  • Excellent communication skills including: technical writing skills, PC skills, presentations and critical thinking and analysis.
  • Experience in managing concurrent complex projects/programs desired.
  • Ability to work effectively in a team environment and with individuals at all levels within an organization.
  • Effective delivery of objectives in a complex matrix environment and effective verbal & written communication skills in a cross functional environment