Method Development Scientist – Pharmaceuticals

Method Development Scientist – Pharmaceuticals (The position has been filled)

• Be a part of Method Development & Validation Team
• Utilise your GLP & GMP Knowledge and Assist with R & D Studies
• Enjoy Working at this Modern Facility in a Friendly and Supportive Team

 

CLIENT

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 and access to parking as well as public transport.

ROLE

As a Method Development Scientist in the Analytical Development team, you will play a critical role in supporting the analytical method development and validation of test methods for finished drug products. Your other duties will include method transfer activities, QC testing, stability testing for Phase I, II and III clinical trials and cleaning validation studies as required.

Should you secure this position, your responsibilities will include:

• Develop, optimise and validate tests methods with HPLC, GC, and MS
• Assist in timely method transfer activities with local and overseas CMOs
• Conduct tests of raw materials, in-process samples, components and finished products
• Perform stability testing for investigative samples for Phase I, II and III clinical trials
• Assist in R&D studies to support the development of new products and CMC data
• 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 GMP, GLP, quality systems and regulatory requirements
• Create reports and documentation (methods/specifications etc)
• When required, perform cleaning validation studies and environmental monitoring for GMP and equipment

REQUIREMENTS

• You will hold a scientific degree, Masters or PhD in a relevant discipline
• You will have significant laboratory experience with and in-depth knowledge of conventional laboratory characterisation techniques such as HPLC, GC and Mass Spectrometry with Waters Empower software
• Proven working experience with method development and validation using HPLC and GC
• Must have proven ability to write sound reports and protocols including method validation documentation
• You will have extensive analytical and experimental design abilities
• Proven problem-solving skills and a solid understanding of GMP and GLP requirements
• Previous experience in developing pharmaceutical generic and innovative drug products
• Ability to use LCMS and GCMS will be highly regarded
• Excellent organisational, proven people and time management skills
• 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.
• 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

To have a confidential discussion about this position please call our Head Office on 03 9516 0100. After Hours: Jo on 0411 197 171

To apply, click the “Apply for this job” button to submit your resume and also a brief covering letter addressing the above selection criteria.

Subsequently, as part of CS Executive Group’s pre-screening process for its clients, candidates who are considered suitable for shortlisting may then be sent formal selection criteria to respond to in more detail.

THANK YOU

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 genuinely cannot respond to each application—only those applicants being considered for shortlisting as candidates are contacted.

If on this occasion you’re unsuccessful, your details will be added to our Talent Pool database. You can visit our website to view all of our current opportunities:

www.csexecutivegroup.com/jobs