Product Development Manager
10 hours ago
Drug Development
- CMC
- Project Management
- “Opioid use disorder is a major and worsening problem in the US and many other countries. New treatment options are needed for managing withdrawal symptoms and helping people to recover from opioid addiction.” Hugh Alsop CEO of Kinoxis Therapeutics._
**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 documentation, review and tracking of 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.
**The Offer**
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.
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