CMC Project Associate – Pharmaceuticals & Medical Devices
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CMC Project Associate – Pharmaceuticals & Medical Devices (The position has been filled)
Further your Career in Supporting an Industry Leading R&D Company
Excellent Facilities and a Culture Positively Fostering Trust, Integrity, Innovation & Teamwork
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 manufacturing and 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 to join their Product Development and Regulatory team.
Reporting to the Nonclinical and CMC Development Manager, this permanent full-time role is based in Melbourne.
The successful candidate will support the Chemistry, Manufacturing and Controls (CMC) activities associated with pharmaceutical research and development projects. You will proactively manage technical requirements, timelines and deliverables for these projects through effective supplier management and collaborative interaction with other team members. You will ensure projects, studies and testing appropriately address the technical and regulatory aspects required for the projects.
Main responsibilities associated with this role include:
Supporting outsourced chemical synthesis, formulation design and development, product manufacture, analytical method development, product testing and analysis, and product logistics (packaging, labelling, and distribution) activities for development/clinical candidates
Supporting internal drug substance manufacturing campaigns and characterisation studies through document preparation, review and management of timelines
Supporting and overseeing outsourced drug product contract manufacturing campaigns and characterisation studies
Preparation of research protocols, technical data review and report preparation for manufacturing and analytical programs
Assisting with clinical trial product logistics for phase 1 to phase 3 clinical trials
Organising regular development-related meetings and telephone conferences with external laboratories including preparing and distributing documentation as required
To be successful in your application you will ideally meet the following criteria:
Minimum of BSc or BSc (Hons) in Chemistry, Biochemistry, Pharmacy or related field
Prior experience in a pharmaceutical development setting, pharmaceutical analytical laboratory, or university research laboratory
Knowledge and/or experience in the various CMC regulatory requirements (e.g., ICH, FDA 21 CFR, GLP, GMP, ISO 13485 regulations) for the development and registration of drug substances and products will be highly regarded
Excellent analytical acumen and attention to detail
Knowledge or general understanding of synthetic chemistry, and the various chemical and analytical methodologies for drug manufacture, drug characterisation and stability assessment (e.g. process chemistry, HPLC, LC/MS)
A work style characterized by diligence and a strong work ethic
Personal attributes of flexibility and responsiveness, including being comfortable in taking direction from others
A good level of computer literacy
Strong organisational skills including the ability to keep detailed records
Excellent time management skills and a good eye for detail are necessary to perform well in this role.
You must have a high level of written and verbal communication skills, be a good team player and a strategic problem solver.
Key to this role will be your flexible “can do” attitude, excellent work ethic and initiative whilst working autonomously but as part of a team.
For a strictly confidential discussion regarding this excellent opportunity please call our team on 03 9516 0100. For enquiries after hours, please call Helen on 0438 620 434.
To apply, click the ‘Apply Now’ button. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.
Thank you for taking the time to apply for these roles. As we receive a large number of applications every day, we can only contact short-listed candidates. If you do not receive a call from our Recruiters, then your details will remain on our database for future suitable roles.
To view other available roles, please visit our website www.csexecutivegroup.com