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| POSITION DESCRIPTION | AUSTRALIAN BIOTECH INDUSTRY MARCH 2009 |
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Analytical Development Manager |
| Position Code: | 38 | | Career Level: | 5 |
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Responsible for
Managing the analytical function to ensure that Analytical service and support is provided to relevant departments such as Research and Development, Quality Assurance & Quality Control, Sales & Marketing and Clinical Trials projects. |
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Reports To
Production Manager, Project Manager, Scientific Affairs Manager, Research Director. |
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Supervises
Potentially a small team of Analytical staff. |
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Main Activities
Overseeing and organising the Analytical testing of development, validation and stability samples as requested.
Ensuring that Analytical work is accurately performed, documented, stored and archived in-line with relevant standards and in-house procedures.
Reviewing , Developing and validating Analytical procedures and processes.
Performing more complex Analytical Development and sample analysis as required.
Review and approve SOP’s, protocols and reports.
Perform internal audits to ensure necessary SOP’s are present and technically correct.
Participating in the development and implementation of safety initiatives that ensure the provision of a safe working environment in compliance with relevant legislation.
Identifying and providing for the training and Development requirements of the Analytical team.
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Key Skills
Demonstrated management experience, proven supervisory skills and ability to identify training needs.
Sound general laboratory skills and experience.
Effective communication, planning and organisational skills.
Competent computing skills with a variety of different software.
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Internal Contacts
Production Manager, Scientific Staff, Customer Service Managers Service and Sales Representatives, IT and Quality Control Staff. |
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External Contacts
Regulatory Bodies (TGA, FDA), Industry Providers, Pre-clinical and Clinical Testing Laboratories and Organisations. |
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Typical Experience
5 - 7 years relevant industry experience coupled with tertiary qualifications in Science such as a Bachelor of Science in Chemistry or equivalent. |
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Other Comments
Alternative title: Analytical Services Manager. |
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