Analytical Scientist – Biotech GMP Facility (The position has been filled)
Australia, Victoria
Full Time
17/05/2017
  • Innovative Pharmaceutical Company with a strong R&D Background
  • Modern facilities with well equipped laboratory
  • Permanent Role with Competitve Salary, Friendly Work Environment & Excellent Career Opportunities

 

CLIENT

Our client is a well known, successful biotechnology company based in Melbourne’s CBD. Due to the success of their innovative products, they continue to grow and excel.

Boasting modern facilities and state of the art laboratories, our client offers a friendly, supportive work environment and access to parking as well as public transport.

 

ROLE

Using innovative technology to deliver drugs across the skin, our client is looking to employ an Analytical Chemist on a permanent basis.

Should you secure this position, your responsibilities will include:

  • Develop and validate stability tests methods for new products with HPLC, GC and MS
  • QC testing of raw materials, in-process samples, components and finished products
  • Perform stability testing for investigative samples across all stages of clinical trials
  • Test and maintain appropriate standards
  • Conduct Root Cause Analysis and close out investigation reports including change control mechanism within a NATA laboratory context
  • Train and mentor staff in the analytical team to obtain a high level of proficiency and ensure consistency
  • Ensure compliance with cGMP, GLP, quality systems and regulatory requirements
  • Creating reports and documentation (methods/specifications etc), including appropriate work for generating IP development and patent applications
  • Creating documentation around Regulatory framework and external publications

 

RESPONSIBILITIES

  • Development of new formulations, and performing test method development/validation
  • Planning and co-ordination of R&D, QC, stability, validation & analytical work within project timelines
  • Establish and carry out formal product stability trials suitable for submissions to regulatory authorities
  • Develop and validate stability indicating HPLC assays for new products
  • Train and coach staff in the R&D and analytical teams
  • Ensure compliance with cGMP, GLP, quality systems and regulatory requirements

 

REQUIREMENTS

  • Bachelor of Science minimum, post-graduate studies will be an advantage
  • At least 5 years experience working as a QC Chemist in a commercial pharmaceutical laboratory
  • Able to use, troubleshoot, maintain and validate HPLC and GC
  • Excellent organisational, proven people and time management skills
  • Strong understanding and commitment GMP/GLP requirements, quality systems and OH&S
  • Strong verbal and written communication skills are essential, as the ability to present scientific approaches, data and interpretations across the company will be important
  • Attention to detail and strong ability to multi-task.
  • Proven ability to troubleshoot and problem solve, including atypical test results
  • The key to this role will be your flexible “can do” attitude and excellent work ethic.
  • Demonstrated ability to display initiative whilst working autonomously or as part of a team.

Our client offers a dynamic environment that fosters a work culture emphasising Innovation, Urgency, Integrity, and Results with a commitment to attract and retain highly motivated and qualified people.

The working environment is one that embodies vision and values, celebrates diversity of background and thought, and supports a balance of professional and personal needs.

 

APPLICATIONS

Please click the ‘Apply Now’ button to submit your application. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.

If you would like to know more about this unique opportunity please call our team at CS Executive Group on 03 9516 0100. After hours you can call Helen on 0438 620 434.

 

THANK YOU

We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of applications we receive daily, we cannot contact all candidates. Please note, if you are not successful on this occasion, your resume will remain on our database and you may be contacted for other similar roles in the future.