Analytical Lead

**Acknowledgement of Country**:
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**The opportunity**:

- Expertise on analytical test methodologies and support the development of new human biological products
- Supportive, rewarding, inclusive and truly flexible environment
- Join CSIRO - Australia's leading scientific research organisation

CSIRO’s Manufacturing Business Unit brings together multi-disciplinary scientific and engineering capabilities using world-class infrastructure to partner with industry in order to develop innovative products and processes to allow Australian manufacturers to be globally competitive and environmentally sustainable.

The Biomedical Manufacturing Research Program works with biomedical companies to deliver new medical treatments and technologies that benefit millions of people in Australia and overseas, helping them live longer, healthier, and more productive lives. This role will be a part of CSIRO’s Regulated Biomanufacturing, Quality Operations team playing a vital role in providing advanced scientific leadership in solving complex problems across a wide range of projects.

As an Analytical Lead, you’ll be accountable for providing leadership support and guidance in the field of Analytical Development for GMP testing of novel vaccines and biotherapeutics for use in preclinical and human clinical studies. Bring your strong expertise in the development of complex analytical methods for the characterisation and quantification of recombinant proteins and antigens for regulated markets. Additionally, share your expert knowledge in the design and management of Quality Control frameworks for testing of new biotherapies including verification, qualification and subsequent tech transfer into cGMP operations.

**Your duties will include**:

- Testing of biological products including physiochemical, biological, protein chemistry, and compendial techniques.
- Developing, transferring, verifying, and qualifying new methods into the CSIRO Biologics Quality Control laboratory, including hands-on leadership of experimental development programs, writing protocols, and reports for qualification of novel or transferred protocols.
- Leading strategic initiatives and facilitating the development/ implementation of new technologies that streamline analytical development, improve throughput, or enhance the quality of services provided to our customers.
- Evaluating new analytical technologies and determining the feasibility/fit/value delivered to CSIRO Analytical development projects.
- Utilising expert knowledge of biological testing requirements and generating phase appropriate specifications and stability programs to support cGMP manufacture following Preclinical, Phase I, and Phase II project requirements.
- Acting as a trusted advisor to the client by utilising knowledge of the client’s business practice and understanding of their underlying needs.
- Partnering with the CSIRO QA Lead and maintaining the testing laboratory in a state of cGMP compliance and audit-readiness in assigned Analytical laboratory functions.

**Location**:Clayton, Melbourne, VIC

**Salary**:AU$131k - AU$153k plus up to 15.4% superannuation

**Tenure**:Specified term of 3 years / Full-time

**Reference**:99357

**To be considered you will need**:

- A relevant degree or equivalent experience in Chemistry, Biochemistry, or related fields.
- Comprehensive industry experience in developing complex analytical methods for the characterisation and quantification of recombinant proteins and antigens for regulated markets.
- Expert knowledge of the design and management of Quality Control frameworks for testing of new biotherapies including validation and transfer into GMP operations.
- Technical expertise and hands-on experience with state-of-the-art LCMS and other instrumentation used in the characterisation of proteins and biologics.
- Experience in leading staff on projects, including setting up effective and efficient teams.
- Extensive experience influencing third parties through communication to gain support for potentially contentious proposals.

For full details about this role please review the Position Description.

**Eligibility**:
**Flexible working arrangements**:
We work flexibly at CSIRO, offering a range of options for how, when and where you work.

**Diversity and inclusion**:
We are working hard to recruit people representing the diversity across our society, and ensure that all our people feel supported to do their best work and feel empowered to let their ideas flourish.

**About CSIRO**:
At CSIRO Australia's national science agency, we solve the