Stability Chemist – Pharmaceuticals (The position has been filled)
Permanent role with well known pharmaceutical company
Develop & validate HPLC analytical methods according to ICH and FDA
Conduct stability testing of Phase I, II & III investigative samples
Our client is a well known, successful biotechnology company based in Melbourne’s CBD. Boasting modern facilities and state-of-the-art laboratories, our client offers a friendly, supportive work environment. Although there is the provision of on-site parking, their office is conveniently located near access points within the city’s public transport system.
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.
Our client is looking for a Stability Chemist to join them on a permanent full-time basis. The main duties associated with this role includes:
Develop, optimise and validate sound analytical methods, in particular HPLC methods, according to ICH and FDA guidelines and compendial requirements as appropriate.
Provide new innovative ideas.
Perform/contribute to stability testing for investigative samples, Phase I, II and III clinical trial samples and registration batches.
Close out laboratory investigation reports, deviations, change controls and CAPA documents in a timely manner.
Prepare QC, stability and analytical documentation for raw materials, in-process samples and finished products.
Assist in research and development studies to support development of products, generation of CMC data for regulatory purposes and to support patent filings for new IP.
Perform cleaning validation studies for the GMP suite and manufacturing equipment.
Support and partake in R&D process improvement initiatives.
Some QC testing of raw materials, in-process samples, components and finished products will be required
Represent the functional area at project team meetings, when required.
BSc/BPharm or equivalent as a minimum. Post-graduate studies will be well regarded
Three or more years of experience in stability testing of pharmaceutical products
Proficient in the use of scientific instrumentation, in particular use of HPLC method development and validation.
Experience of instrument validation including installation, operation and performance qualifications, especially software validation desirable but not essential
Proficient use of Waters Empower™ software.
Proficient in the use of MS Office computer software, in particular, Excel and Word
Able to make responsible decisions on assigned matters, establish professional scientific standards and procedures, consult, recommend and advise in speciality scientific areas.
Ability to troubleshoot and solve problems.
Ability to make original contributions or apply new professional scientific approaches and techniques.
Very good written and verbal communication skills.
Ability to plan and conduct work with minimal supervision, including coordination of self and scientists.
Please click the ‘Apply Now’ button to submit your application. Please ensure you attach a Resume and Cover Letter in Word Format addressing the above requirements.
If you would like to know more about this unique opportunity please call on (or SMS after hours): –
0411 197 171 – Jo
0438 620 434 – Helen
CS Executive Group would like to thank you in advance for taking the time to apply for this role. Unfortunately, due to the large volume of correspondence our recruitment team receives on a daily basis, we can only contact applicants being considered for shortlisting as candidates.
However, if on this occasion you’re unsuccessful, please note your details will be added to our Talent Pool database.