- Further your career in supporting an Industry Leading R&D company
- Technology Agenda
- Excellent facilities and a positive culture which fosters trust, integrity, innovation and teamwork
Our client is a highly respected leading biotechnology company with excellent facilities and a friendly, supportive work environment. Due to an increasing workload as the company’s portfolio of products grow, they are seeking a Development Projects Manager to join their Product Development and Regulatory team.
This permanent full-time role which is based in Melbourne, aims to advance drug development and medical device related projects.
The successful candidate will proactively manage costs, timelines, and technical requirements and deliverables for these projects through effective supplier management and collaborative interaction with other team members.
A strategic thinker and experienced manager, you will ensure projects, studies and testing address the technical and regulatory aspects of the projects being managed and are being conducted under an appropriate commercial framework.
In addition to the above, other duties of this role include:
- Management, direction and oversight of nonclinical and CMC-related development projects.
- Management, direction and oversight of biological studies, including elucidation of biological activity and mode of action of development candidates.
- Nonclinical toxicology study design and management in conjunction with other members of the Development team.
- Effective and proactive planning of development projects.
- Input into late-stage/commercial production activities, including consideration of regulatory requirements, and effective communication with the Supply Chain function to ensure both commercial objectives and regulatory requirements are met.
To be successful in your application you will need to meet the following criteria:
- Minimum of a BSc in Chemistry, Biology, Analytical Chemistry, Biotechnology or similar; PhD preferred.
- Five to ten years’ experience in a role that has strengthened your ability to project manage development programs. Your background may have included conduct or oversight of nonclinical studies, process or analytical chemistry, oncology-related work or product development.
- Exposure to quality systems, regulatory affairs, and aspects of product development including manufacturing scale-up, method validation, design of nonclinical studies and active management of suppliers will be advantageous in this role which draws on a number of skills senior scientists are exposed to.
- Previous experience with CMC aspects of development projects and knowledge of Microsoft Project will be highly regarded.
- 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.
- Ability to identify, analyse and manage risks associated within areas of responsibility and expertise.
- Awareness of and compliance with GMP, GLP, GCP and Occupational Health and Safety regulations
- 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. Further your Career in Supporting an Industry Leading R&D Company Technology Agenda Excellent Facilities and a Culture Positively Fostering Trust, Integrity, Innovation & Teamwor…Territory (Sales) Manager (Medical Devices) As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany…Responsible for our Urology and Critical Care (UCC) portfolio, Develop and execute marketing strategy across ANZ, Sydney or Melbourne based. BD is one of the largest global medic…