Posted: 10 September 2021
Our client, a Melbourne based biotechnology company, has developed a unique world leading platform technology that enables site specific drug delivery. Their technology involves development of patented polymeric prodrugs that can be engineered into various product forms. The company now seeks to build on its capabilities to continue their transition from R&D to clinical development.
Our client is seeking an exceptional candidate to manage the Quality Control Requirements for the company. Your primary responsibility will be to setup and manage a new Quality Control Laboratory and implement the quality system to achieve TGA certification. The QC lab will support the manufacture of our client’s drug products for clinical trials. Reporting to the Head of Product Development & Technical Affairs, and with 3 reports, your remit will include;
- Manage the schedule of QC release and stability testing, investigational testing, feasibility / qualification / validation studies, and other deliverables.
- Final approval of all raw materials and intermediates and finished goods.
- Actively oversee and supervise the change control system, documentation systems and product release.
- Provision of cGMP training and assessments of training & preparation for audits.
- Provide review and support to deviations, out-of-specification/out-of-trend results, unexpected events, lab investigations and corrective and preventative actions.
- Oversee the administration of analytical laboratory equipment systems and software (e.g., Empower, LIMS etc.) including purchase, calibration, qualification and requalification activities, maintenance etc.
- Oversee the QC lab support functions: capacity planning, lab space management, inventory/ordering/stocking.
- Ensure that all processes and methods required by QC have appropriate methodologies.
- Provide leadership to instil a continuous improvement culture within QC and QC related activities.
- Degree Qualification – Science / Chemistry discipline.
- Five years supervisory experience in a Quality environment within the pharmaceutical industry; broad experience of regulatory and cGMP activities
- Strong experience in QC analytical testing planning and scheduling for raw materials, in process samples, API and finished products and cleaning verification samples.
- Proficiency with various analytical techniques: HPLC, GPC, GC, UV, IR, dissolution, titration, wet chemistry,
- Knowledge of TGA, FDA and other regulatory agency regulations, pharmaceutical compendia and audits.
- Prior experience managing people and providing strategic leadership to the quality organization.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Passion for the development of new technologies.
Our client offers an exceptionally dynamic and progressive work environment. This role is at the frontline of the development of new innovative technologies. As a valued member of the team, you will have the opportunity to demonstrate your talent and shape this exciting company.
To join our client in this exciting opportunity, please email your cover letter & CV to firstname.lastname@example.org.
Confidential enquiries to Marilyn Jones on 1300 0 MEXEC