R&D Scientist - HPLC

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CSL Limited, (Parkville, Australia) ABN 99 051 588 348
Document Type:
Page:
Position Description
1 of 3
Title:
Senior Scientist – Bioanalytical Sciences
Department Name:
Bioanalytical Sciences
Department Number: 831
Document No:
Edition:
DPD 0050
2.00
©CSL Limited, 2016
LOCALLY CONTROLLED DOCUMENT
This document is subject to copyright and is confidential. This document has been prepared solely for the use of CSL Limited. Any
unauthorised use or disclosure or copying is strictly prohibited.
Position Title:
Senior Scientist – Bioanalytical Sciences
(L & D 831011, 831003, 831006, 831008)
Department:
831 - Bioanalytical Sciences
Division:
R&D
CSL Level:
CSL 5
Employment Type:
Full Time
Summary of Role:
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To develop test methods from first principles for characterisation and product release of R&D
developed material
Trouble shoot assay methods as required
Qualify and Validate developed assays according to appropriate guidelines
Perform these assays as a service to external/internal clients as required and report results
Play a role in the Technical Transfer of methods in and out of D831
Develop test methods/assays using the following skill sets and techniques - electrophoresis,
amino acid compositional analysis, protein sequencing, glycoanalysis LC/MS, Biologic assays,
HPLC based assays, mass spectrometry LC-MS/MS including software used to sequencing
MS/MS data and identify post translational modifications, Ability to train other scientific staff
To write scientific protocols and reports for regulatory submissions
Reporting Structure:
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The position reports to a Senior Scientist Supervisor.
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This position may have direct reports.
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Title: Senior Scientist- Bioanalytical Sciences
Page 2 of 3
RESPONSIBILITIES
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Design, perform and interpret analytical data
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Critically analyse experimental designs and results
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Consult with other scientists as required
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Maintain records of all laboratory work to Good Scientific Practice (GSP) standards
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Develop analytical methods suitable for characterisation, release testing and stability testing
of biopharmaceuticals
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Seek out and research new technologies and laboratory practises to enhance the groups
capabilities and to be aware of and utilise as appropriate, current international standards
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Write protocols and reports for assay development, assay qualification, and product
characterisation studies
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Prepare test procedures, standard operating procedures (SOPs) and data collection forms,
where required
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Present progress updates and experimental results at project meetings
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Ensure high safety standards within the areas of responsibility are taken into account and
adhered to as governed by local, state and federal regulations, laws and policies as well as
CSL’s policies and directives
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Other tasks as required by the department
Key Relationships (both internal and external)
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Department Head
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Bioanalytical Sciences department staff
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Staff in the R&D Product Development groups
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Quality Control
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Quality Assurance
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Regulatory Affairs
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Vendors/Suppliers
Job Environment
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This position is located at the Parkville site.
Document No: DPD 0050
D:\533563452.doc
CONFIDENTIAL
Edition: 1.00
17 February 2016
Title: R&D Scientist - HPLC
Page 3 of 3
POSITION SPECIFICATION
Essential Qualifications/Experience:
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A tertiary degree including Honours (or equivalent), in biochemistry, chemistry and/or
analytical chemistry, mass spectrometry, or a related field
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At least five years laboratory experience in separation sciences or protein biochemistry, or
pharmaceutical sciences with an emphasis on instrumental analysis
Essential Skills, Knowledge & Attributes:
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Significant experience in either HPLC / chromatographic separations, or in mass
spectrometry
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Outstanding verbal and written communication skills
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Well organised; able to plan work appropriately
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Ability to work effectively in a team
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Attention to detail
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Troubleshooting capabilities
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Familiarity with software for controlling analytical instruments, e.g. Empower or
Chemstation for HPLC, Masslynx, Xcalibur or DataAnalysis for MS
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Previous experience in biomolecule chemistry, e.g. natural products, or glycoanalysis
would be of advantage
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Experience in protein chemistry techniques such as Biacore binding analysis, amino acid
analysis, N-terminal sequencing, or knowledge in Bioinformatics of proteins would be of
advantage
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Good working knowledge of Word Processing, Spreadsheets and general PC familiarity
and usage
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Scientific report writing and presentation skills
DESIRABLE CRITERIA
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Higher postgraduate qualifications, e.g. PhD, will be well regarded
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Previous exposure to the Pharmaceutical Industry will be well regarded
Document No: DPD 0050
D:\533563452.doc
CONFIDENTIAL
Edition: 1.00
17 February 2016
Title: R&D Scientist - HPLC
Page 1 of 1
DOCUMENT CROSS REFERENCE
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Sheryl Aylward
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APPROVAL TABLE
Title
Name
Senior Scientist
Supervisor
Nancy Guzzo-Pernell
Associate Director,
Bioprocess
Development
Patricia Stewart
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3 Years
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