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Product Development Managermexec
Drug Development CMC Project Management The Client Kinoxis Therapeutics Pty Ltd (Kinoxis) is a private, Australian-based, clinical stage biotechnology company developing first-in-class therapeutics to address the escalating demand for effective treatments for substance use disorders and social dysfunction in neurological and psychiatric disorders. Now is an exciting time to join their team as they undergo further expansion. The Opportunity Reporting directly to the Vice President, Drug Development, you will project manage all CMC activities associated with their drug development program.
You will plan, coordinate and support all aspects of drug substance and drug product supply. Bringing strong communication skills, you will manage their ongoing collaborations with CDMOs to ensure success. Facilitate planning of CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments, including the provision of logistics and supply chain management support.
Support CDMO activities associated with clinical supply, including technical transfer, vendor assurance, and documentation, review and tracking of manufacturing and stability programs. Support writing, review, publication, and filing of CMC-related regulatory documents including those associated with INDs and product registration submissions. The Requirements Tertiary-level qualification in chemistry, pharmacy, molecular biology, or related field.
At least 5 years of experience in product development managing CMC activities, projects, and budgets in a cGLP/cGMP environment. Strong understanding of the drug development process within a regulatory environment, ideally relating to small molecule drug candidates. The Offer For more information on this new and exciting opportunity, you can email careersmexec.
com or contact Mark Thomas or Marilyn Jones at 1300 0 MEXEC for a confidential discussion. Please note that only applications made through mexec will be considered for this recruitment. mexec delivers executive recruitment solutions to the pharmaceutical, biotechnology and broader technology industries.
mexec comprises of highly talented and knowledgeable industry experienced Consultants that partner with leading organisations to grow their leadership teams. We recruit at all levels including senior management, and we are currently recruiting for a variety of opportunities in the area of Sales & Marketing, Management, Medical, Regulatory Affairs, Clinical Research, Pharmacovigilance and Operations. Contact us today.