Scientific Associate II (Analytical Chemistry / Separation)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Nov 12, 2020
Ref
R-123809
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

Job Summary

The individual will provide support on LC-UV/MS method development for release and characterization of proteins and RNAs. The incumbent will perform sample testing of UPLC/HPLC analytical characterization of bulk samples, strain surveillance, and process development. He/she will contribute to analytical assay development, qualification, and in-process control to support product and process development, release and characterization of Tox and CTM.

Major Accountabilities

Supportive Work:

- Performs qualitative and quantitative LC-MS analysis of viral vaccine candidates and standards under limited supervision/guidance.

- Executes analytical UPLC and HPLC assays following SOPs in support of vaccine process and product development programs.

- Works across between Mass Spec and Separation Science Teams, works closely with Biochemistry, and Molecular & Cellular Biology groups within TD-Global Analytical Development.

- Provides support on reviewing documentation in notebooks and reviewing data in LIMS for specific lab based processes.

- Able to work under tight deadlines.

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

- Partners with diverse team members from various functions, countries and members at various levels in the organization.

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

- Functions effectively as a core team member.

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

Minimum Requirements

• B.S. with 2+ years of industry experience

2+ years of industry experience with hands on experience on mass spectrometry and UPLC

• Experience in pharmaceutical development in one or more of various disciplines including (but not limited to) Analytical Chemistry, Biochemistry, Biomolecular Sciences, etc. Hands on experience required for LC-MS method development on large and/or small molecule analysis

• Proficient in operating and maintaining Thermo's Vanquish UHPLC, TSQ and Orbitrap MS systems

• Experience with using MS software programs: TraceFinder, Chromeleon, Xcalibur

• Has in-depth conceptual and practical expertise in UPLC

• Hands on experience with RNA analysis is highly desired

• Basic understanding on SILAC based protein quantitation is beneficial

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

• Data collection and reporting with knowledge of GLP/GMP environments preferred

• Good verbal & written & presentation communication skills in a cross functional environment

• Attention to detail is a must

• Proactively owns and drives assigned tasks to completion

• Ability to work within a matrixed team environment is essential