CSL Limited, (Parkville, Australia) ABN 99 051 588 348
Document Type:
Page:
Position Description
1 of 5
Title:
Department Name:
Preclinical Purification
Development
Department Number: 825
Purification Scientist
Document No:
Edition:
DPD0084
1.00
©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:
Purification Scientist
(L & D 825014, 825025, 825026)
Department:
825 - Purification Development
Division:
R&D
CSL Level:
CSL 4
Employment Type:
Full Time
Summary of Role:
Contribute as a team member

To the development of robust and scalable purification processes of recombinant proteins from
primary cell cultures.

Scale up and validation of new product processes

Manufacture of material under GMP conditions for preclinical and clinical evaluations

Technology transfer to the end user

Protein biophysical characterisation using a variety of biophysical and activity assays

Maintain and operate the dedicated facilities and systems used by the group to the appropriate
standard

Preparation of critical records of the experimental work being carried out.
Reporting Structure:

Position reports to Senior Scientist and/or Senior Scientist Supervisor in Purification Development
within the Research and Development Division

The person holding this position should be capable of assisting in the supervision of a level 3
scientist.
Document No: DPD0084
D:\116096473.doc
CONFIDENTIAL
Edition: 1.00
12 February 2016
Title: Purification Scientist
Page 2 of 5
RESPONSIBILITIES

Purification processes design, development and optimization with some guidance from
the supervisor

Carry out appropriate protein and process characterisation studies

Assist with the design and development of appropriate in-process and characterisation
assays

Assist with scale up, optimisation and tech transfer activities to the manufacturing
department and/or appropriate commercial manufacturing sites.

Generation of accurate, reliable data to support purification process development

Assist with generation of documents associated with new processes including standard
operating procedures, study and validation protocols and reports, batch procedures and
data collection forms and work books to GSP and GMP standards.

Provide training in process procedures and equipment operations to other staff.

Maintain Laboratories and facilities to GSP/GMP & regulatory standards (OGTR, OHS)

Preparation of proteins suitable for preclinical and clinical trials in the Clinical
Manufacturing Facility under GMP

Source and order required raw materials and equipment required to support studies

Represent the group at various meetings as required

Responsible for setting a personal work plan

Be flexible and adaptable to changing work place priorities

Ensure high safety standard 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.
Document No: DPD0084
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CONFIDENTIAL
Edition: 1.00
12 February 2016
Title: Purification Scientist
Page 3 of 5
Key Relationships (both internal and external)
Internal

Departmental Heads

Quality Control testing departments

Scientists

Formulation Scientists

Fermentation & Cell Culture Scientists

Team leaders

Quality assurance advisors

Regulatory affairs

Support staff (central services, validation, engineering etc)
External

Suppliers of raw materials and equipment

Project collaborators and scientist
Document No: DPD0084
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CONFIDENTIAL
Edition: 1.00
12 February 2016
Title: Purification Scientist
Page 4 of 5
Job Environment

This position is located at the Parkville site
POSITION SPECIFICATION
Essential Qualifications/Experience:

Degree in Biochemistry, Chemistry, Biotechnology or Engineering and at least 3-years
industry experience in purification development. OR

PhD in relevant discipline
Essential Skills, Knowledge & Attributes:

Ability to contribute and work in a cross-functional, multi-disciplinary team environment

Solid experience in protein purification techniques and operation of chromatography
systems, AKTA.

Experience in protein biophysical characterisation techniques such as HPLC, SDS-Page,
Western Blots, UV/Vis spectrophotometry.

Experience in activity assay methodology.

An understanding of experiment and validation design (DOE) and the requirements when
documenting protocols for these exercises

An understanding of the parameters involved in scaling up of purification processes.

Understanding of potential post-translational protein modifications and how to detect and
avoid them

Excellent written (Technical/scientific), oral communication and presentation skills

Competence in data analysis and reporting

Mechanical aptitude and problem solving skills

Computer literacy and familiarity with MS Office applications

Time management skills

Enthusiastic and responsible approach

Detail oriented, self-motivated and committed to the profession

Be flexible and adaptable to changing work place priorities and willing to undertake work
in other Bioprocess Development areas
Document No: DPD0084
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CONFIDENTIAL
Edition: 1.00
12 February 2016
Title: Purification Scientist
Page 5 of 5
Desired attributes

Affable, personable, co-operative, self-motivated individual.

Following through and finishing off tasks and capable of honouring agreed time lines

Able to react well to change

Formal statistical DOE skills

Understanding of and experience in GSP and GMP processes and facilities and principles
of validation.
Document No: DPD0084
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CONFIDENTIAL
Edition: 1.00
12 February 2016
Title: Purification Scientist
Page 1 of 1
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