QC Team Leader – Stability

QC Team Leader – Stability (The position has been filled)

• Parental-Leave Cover for Role at a Well-Known Pharmaceutical Company
• Lead a Small Team of Analytical Scientists Conducting Stability Testing
• Ensure Testing of Investigative Samples Meet ICH Guidelines

 

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. 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.

 

WORKING HOLIDAY VISA HOLDERS

Holders of working holiday visas engaged in critical sectors, which includes the health care industry, have been given permission from the Department of Home Affairs to work for the same employer for longer than six months. Accordingly, CS Executive Group warmly encourages anyone holding a valid subclass 417 visa (with at least 12 months left before their expiration) to apply.

 

ROLE

Our client is looking for a Senior Analytical Scientist to join them to cover for a staff member away on parental leave. The main duties associated with this role includes:

• Develop, optimise, and validate sound analytical methods, in particular HPLC 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;

• 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 the 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 and

• Represent the functional area at project team meetings, when required.

 

REQUIREMENTS

• BSc/BPharm or equivalent, at the minimum, and postgraduate studies being well regarded;

• Highly proficient in the use of HPLC/UPLC, which includes experience with method development and validation;

• Familiarity with using Waters Empower™ software as a CDS is essential;

• Whilst not essential, experience with instrument validation (i.e., IQ, OQ & PQ) is desirable and so is software validation;

• Proficiency with MS Excel & Word is a prerequisite;

• Proven capacity to make responsible decisions on assigned matters and also the ability to consult, recommend, and advise in speciality scientific areas;

• Capability to troubleshoot and solve problems that can and do arise within a busy analytical laboratory;

• Excellent written and verbal communication skills; and

• Well-developed interpersonal skills honed from prior roles with a responsibility for leadership of a team.

 

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 above requirements.

If you would like to know more about this unique opportunity then send a message to [email protected]

 

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 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.