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R&D Analytical Manager – Biotechnology
Exciting R&D leadership role with cutting-edge biotech company
Direct the characterisation of new molecules as API candidates
Hands-on laboratory role with supervisory responsibilities
Our client is a well-known, successful biotech company based in Melbourne. Due to the success of their innovative products in Australia and abroad, they continue to grow and excel.
Boasting modern facilities and a wide array of sophisticated analytical equipment, they offer a friendly and supportive work environment where people respect each other and work together to achieve common goals. Everyone contributes to the success of the organisation. With a focus on working safely whilst delivering the best quality products as efficiently as possible, they seek a down-to-earth, collaborative individual to join their Analytical Group.
This full-time position is ideal for an experienced Method Development Scientist who has experience working within an analytical drug development environment and has strong experience in the research of new techniques, relating to the characterisation of new molecules.
Some of the main duties associated with this permanent role include:
Provide technical oversight and contribute strategic direction to the analytical group that ensures it can adequately characterise novel compounds using cutting-edge analytical techniques;
Explore new techniques in order to characterise new molecules and develop methods using HPLC, UPLC, UHPLC, and LCMS (ToF);
Lead an existing team of qualified scientists and, whilst individually respecting their skills and experience, foster their professional development in anticipation of the analytical group’s future needs;
Take a hands-on role in the development of new analytical methods for the characterisation of novel molecules, which makes use of the full array of techniques available within the laboratory;
Author method development reports, ICH/EMA/FDA compliant analytical method validation protocols and reports, and related documents;
Liaise with internal and external collaborators, where appropriate, in the preparation of project proposals and presentations;
Review analytical API batch release data, API stability data, and raw material test results, which includes providing approval under GMP requirements;
Assist with the management of resource allocation across concurrent research activities, which includes monitoring and reporting on the progress of multiple projects against agreed milestones;
Identify, analyse, and manage risks associated within areas of responsibility and expertise; and
Take responsibility for the collation of all relevant analytical release data, stability data, and method validation information necessary for documentation submitted for approval through the Regulatory team.
A true team player, the ideal candidate will need to meet the following criteria:
A BSc or BSc (Hons) in Chemistry or Biochemistry, with a research higher degree in Analytical Chemistry or a related field being well regarded;
Prior experience (minimum of 5 years) in a pharmaceutical R&D laboratory or a university research laboratory heavily collaborating with the Pharma Industry;
Prior supervisory/managerial experience of a small team is essential;
Demonstrable hands-on method development competency with HPLC, UHPLC & UPLC, particularly in combination with ToF MS, for the characterisation of novel molecules;
You must have knowledge of GMP, FDA,and/or ICH regulations and guidelines, sufficient for the preparation of compliant protocols, reports, and related documentation;
A thorough appreciation of CMC regulatory requirements (e.g., ICH, FDA 21 CFR, GLP, GMP, ISO 13485 regulations) for the development and registration of drug substances and products;
Capability to research and develop new methods to overcome any barriers preventing existing analytical technique from being used;
Confidence in reviewing complex test results from the analysis of raw materials and APIs through to signing off formally on their approval;
Exceptional organisational skills are a prerequisite, which includes an ability to keep detailed records; and
Superb interpersonal skills with a capability to deal effectively and respectfully with a wide range of personalities.
This is an opportunity for a suitably experienced candidate to join a growing Australian cutting-edge Biotech Company. Accordingly, if you have a flair for analytical chemistry and the necessary supervisory skills, we want to hear from you!
Please click the ‘Apply Now’ button to submit your application. Please ensure you attach a Resume and Cover Letter in Word Format addressing the selection criteria above.
If you would like to know more about this unique opportunity, please call Dan on 0415 573 220 or Jo on 0411 197 171. Or send an email message to [email protected]
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 daily, we genuinely cannot respond to each application—only those applicants being considered for shortlisting as candidates are contacted.
If on this occasion you are unsuccessful, your details will be added to our Talent Pool database.