Chemistry Manufacturing and Controls (CMC) Manager – Oncology Drug Development - Remote

Overview

• ASX-listed oncology drug development company
• Full-time continuing position (remote) with competitive remuneration package
• Leadership of API and Drug Product R&D and GMP manufacturing programs, including regulatory compliance

About The Company Race Oncology (soon to be Racura Oncology) (Race) is an ASX-listed Phase 3 clinical biopharmaceutical company with a dedicated mission to be at the heart of cancer care. Race's lead asset, RCDS1 (E,E-bisantrene), is a small molecule anticancer agent that primarily functions via G-quadruplex-DNA & RNA binding, leading to potent inhibition of the important cancer growth regulator MYC. RCDS1 has demonstrated therapeutic activity in cancer patients and has a well characterised safety profile. Race is advancing a proprietary formulation of RCDS1 (RC220) to address the high unmet needs of patients across multiple oncology indications, with a Phase 3 clinical program in acute myeloid leukaemia (AML), a Phase 1a/b program in mutant epidermal growth factor receptor non-small cell lung cancer (EGFRm NSCLC), and a Phase 1a/b program in combination with the anthracycline doxorubicin, where we aim to deliver both cardioprotection and enhanced anticancer activity for solid tumour patients. About The Role Race is seeking an outstanding scientist to lead the company’s chemistry, manufacturing and controls (CMC) of both our drug substance and drug product. In this senior management role, you will be accountable for CMC sections on all regulatory submissions. The successful candidate will work closely with external consultants and Australian and international contract development and manufacturing organisations (CDMOs) to ensure Race’s CMC and regulatory milestones are achieved in an efficient, timely and cost-efficient manner. You will need to be able to work independently, while liaising with Race’s preclinical and clinical teams. In this full-time position, you will report directly to Race’s Chief Executive Officer (CEO). Essential For The Role

• Ph.D. or equivalent in chemical or pharmaceutical sciences
• Minimum 5 years of experience leading pharmaceutical company CMC programs
• Proven track record of outstanding written and verbal communication
• Demonstrated leadership in CMC regulatory submissions
• Ability to build rapport and credibility with key regulators, consultants, and other stakeholders
• An interest in oncology drug development and commercialisation
• Ability to work collaboratively across disciplines with attention to detail
• Ability to travel domestically and internationally as required by the company

Desirable for the role

• Laboratory experience in drug substance and drug product manufacturing
• Experience working with high potency APIs and knowledge of their regulatory requirements
• Background in the development of oncology drug products