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: 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: The position reports to a Senior Scientist Supervisor. This position may have direct reports. D:\533563452.doc 17 February 2016 Title: Senior Scientist- Bioanalytical Sciences Page 2 of 3 RESPONSIBILITIES Design, perform and interpret analytical data Critically analyse experimental designs and results Consult with other scientists as required Maintain records of all laboratory work to Good Scientific Practice (GSP) standards Develop analytical methods suitable for characterisation, release testing and stability testing of biopharmaceuticals 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 Write protocols and reports for assay development, assay qualification, and product characterisation studies Prepare test procedures, standard operating procedures (SOPs) and data collection forms, where required Present progress updates and experimental results at project meetings 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 Other tasks as required by the department Key Relationships (both internal and external) Department Head Bioanalytical Sciences department staff Staff in the R&D Product Development groups Quality Control Quality Assurance Regulatory Affairs Vendors/Suppliers Job Environment 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: A tertiary degree including Honours (or equivalent), in biochemistry, chemistry and/or analytical chemistry, mass spectrometry, or a related field 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: Significant experience in either HPLC / chromatographic separations, or in mass spectrometry Outstanding verbal and written communication skills Well organised; able to plan work appropriately Ability to work effectively in a team Attention to detail Troubleshooting capabilities Familiarity with software for controlling analytical instruments, e.g. Empower or Chemstation for HPLC, Masslynx, Xcalibur or DataAnalysis for MS Previous experience in biomolecule chemistry, e.g. natural products, or glycoanalysis would be of advantage 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 Good working knowledge of Word Processing, Spreadsheets and general PC familiarity and usage Scientific report writing and presentation skills DESIRABLE CRITERIA Higher postgraduate qualifications, e.g. PhD, will be well regarded 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 Document Cross Reference table internal and external Documents Document Number Document Title Database Links Other References DOCUMENT Edition Effective Date 1 Prepared by/Author Change Control No. Description of Change Sheryl Aylward N/A Original APPROVAL TABLE Title Name Senior Scientist Supervisor Nancy Guzzo-Pernell Associate Director, Bioprocess Development Patricia Stewart Signature Date Prepared by/Author Copy no. / / Approved by Approved by Document Delegate Review period (Yrs) 3 Years R & D Document Controller / / / / Approved by File Properties Template Data Document No: DPD 0050 D:\533563452.doc Effective Template Document No.: Last Saved: CONFIDENTIAL / Template Edition No. Edition: 1.00 17 February 2016 /