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Senior Analytical Scientist – Pharmaceuticals X 2 (The position has been filled)
Two permanent roles with well-known, growing pharmaceutical company
Develop and validate HPLC & GC 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.
The working environment is one that values and celebrates diversity of background and thought, which sees our client support its employees in balancing their professional and personal needs.
Our client offers a dynamic environment that fosters a work culture emphasising Innovation, Urgency, Integrity & Results—with a commitment to attracting and retaining highly motivated and qualified people.
Our client is looking for two permanent full-time Senior Analytical Scientists. The main duties associated with these roles will require you to:
Assist in ensuring adherence to pharmaceutical regulatory requirements throughout the product development, quality control (QC) and stability programs as required;
Perform and ensure work is of a high quality work standard and in accordance with GLP, GMP and required timeframes;
Assist with research and development studies and support IP filings; and
Develop and validate methods for drug product stability studies and other studies for product development programs.
To achieve the above-stated duties, you will undertake the following tasks:
Develop, optimise and validate sound analytical methods, specifically HPLC (and GC) methods, according to ICH & FDA guidelines and compendial requirements as appropriate;
Provide new innovative ideas;
Perform QC testing of raw materials, in-process samples, components, and finished products;
Perform/contribute to stability testing for investigative samples, Phase I, II & III clinical trial samples and registration batches;
Ensure laboratory investigation reports, deviations, change controls, and CAPA documents are closed out in a timely manner;
Prepare QC, stability, and analytical documentation for raw materials, in-process samples, and finished products;
Train new staff and mentor existing staff to ensure the highest level of proficiency and ongoing compliance with in-house methods and procedures;
Assist in R&D studies that support development of products, generation of CMC data for regulatory purposes, and support filing of patent for new IP;
Perform cleaning validation studies for the GMP suite and manufacturing equipment;
Support and partake in R&D process improvement initiatives;
Represent the functional area at project team meetings, as required; and
Attend in-house and external training relevant to the role.
BSc/BPharm or equivalent as a minimum, with relevant postgraduate studies being well regarded;
Proven capability to develop and validate HPLC (and GC) methods, according to ICH and FDA guidelines;
Knowledge of pharmaceutical manufacturing processes (GMP/GLP), with a level of familiarity with transdermal drug delivery technology desirable but not essential;
Experience undertaking IQ, OQ & PQ activities associated with the validation of instrumentation, with software validation desirable but not essential;
Proficient in the use of Waters Empower and MS Office software (i.e., Excel & Word);
Possess the expertise necessary to be able to make informed decisions on assigned matters, establish professional scientific standards and procedures, and consult, recommend, and advise in specialty scientific areas;
Competency beyond that needed to troubleshoot and solve routine problems, so as to be capable of making original contributions to projects or championing new scientific approaches/techniques;
Prior responsibility for the writing of reports, SOPs, and/or technical documentation is a must-have; and
Team leadership skills that demonstrate how you coordinate your own activities with those of junior colleagues around you.
If you would like to know more about this unique opportunity please call or SMS (after hours): –
0415 573 220 – Daniel Turner
0438 620 434 – Helen Patronis
Please click the ‘Apply Now’ button to submit your application, ensuring that you attach an up-to-date resume and a cover letter in MS Word format that addresses the above requirements.
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.