Scientist II (Technical Development) LC-MS

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Sep 29, 2021
Ref
R-148522
Required Education
Associate Degree
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:

Will lead the Liquid Chromatography -Mass Spectrometry based method development for characterizing proteins, mRNAs and lipid nanoparticles (LNPs) in support of vaccine development, production, process related investigations and improvement.

Responsible for assay transfer and qualification to support CTM release, in-process control, IND and BLA filing. In addition, the individual will work closely with scientists across different functions for process improvement and product formulation optimization.

Mentor junior scientific associates in a matrix R&D environment.

Major Accountabilities:

1.           Development Work:

- Designs and executes experiments for qualitative and quantitative LC-MS analysis of viral vaccine candidates and standards

- Contributes to method qualification to support process and product development

- Evaluates novel analytical technologies, proposes new analytical methods or improvements to current methods

- 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

- Leads the development and execution of strategies, plans, and methods to enable product and process development, and method transfers

- Authors study protocols, characterization reports, and/or scientific manuscripts for external publication and patent application

- Ensures all experimental procedures and documentation are compliant with highest quality and regulatory standards

2.           Operations/Quality Support:

- Serves as a primary or secondary interface representing the group 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.

-Acts as an SME 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.

3.           People Management:

-Provides guidance and mentorship to less experienced colleagues and team members

4.    Other:

– Completes individual training and maintains a state of compliance

– Adheres to all safety requirements

– Supports communication/updates as required

Minimum Qualifications:
  • Master’s degree or Ph.D. in biochemistry, biophysics or other chemistry related scientific field required.
  • Minimum of 7+ years of experience and a Masters degree or Ph.D. with 4+ years
  • Must have extensive experience with LC-MS method development for large molecule analysis; experience with method qualification and sample testing in a GxP environment is highly desired
  • Highly proficient in utilizing Thermo’s LC-MS systems: Vanquish Duo, TSQ, Orbitrap XL and Exploris instrument
  • Familiar with MS data analysis software: TraceFinder, Chromeleon, BioPharma Finder, Skyline and Mascot Database Search Engine
  • In-depth knowledge on protein and/or mRNA chemistry is also a must; having background in molecular biology or cell biology is a plus
  • Able to work on multiple projects at the same time in a fast-paced R&D environment
  • Must be detail oriented to minimize human errors in performing experiments
  • Able to independently design experiments and perform data analysis/interpretation to draw solid conclusions
  • Proactively identify novel approaches to improve existing assays as a scientific leader in the related field
  • Demonstrated leadership abilities through project management
  • 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
  • Effective verbal & written & presentation skills in a cross functional environment
  • Ability to work within a matrixed team environment is essential