18 July 2019
(Applications close – 16 Aug 2019)
· Clinical drug development · CMC · Management Team
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 management and development capabilities to continue the transition from R&D to clinical development.
Reporting to the CEO, our client is seeking an exceptional candidate to join their management team. Your primary responsibility will be to lead, direct and manage the product development process. You will be responsible for all product development & CMC (chemistry, manufacture & control) activities including third party collaborations, internal analytical, production and clinical development. The incumbent would be expected to play a hands-on role designing, improving and implementing systems the company uses to produce or deliver its products.
♦ Lead key business operations to develop & supply product for human clinical trials.
♦ Manage all Chemical, Manufacturing & Control (CMC) activities.
♦ Manage internal & external analytical chemistry capabilities including a staff of 6.
♦ Work with stakeholders to prepare technical reports & regulatory documents.
♦ Work with management to develop project planning for programs across the entire business.
♦ Manage third party engagement, including research services providers, CROs & CMOs.
♦ Chair regular R&D meetings to ensure business goals are met.
♦ Work with QA to ensure CMC and product related information documentation.
♦ Proven management experience at a senior level within a pharmaceutical/biotechnology/medical devices organisation.
♦ Over 5 years’ experience in product development managing CMC activities, project management & budgets in a cGLP/cGMP environment.
♦ Proven ability to write original documents including manufacture batch reports, specifications, SOPs; clinical and stability study protocols, investigational brochures and regulatory briefing documents.
♦ Tertiary qualifications preferably to PhD level or extensive experience in a related scientific discipline.
Our client offers an exceptionally collegiate and supportive work environment. They expect, and provide, excellent professional standards and work ethics with a ‘hands on’ attitude. Successful candidates will attract a competitive salary package. As a valued member of this team, you will have the opportunity to demonstrate your talent and shape this emerging business.
If you are interested in joining our client in this exciting new challenge, please call Marilyn Jones on 0437 332 272 for a confidential discussion and/or email your résumé with your cover letter: email@example.com Candidates that are successful for interview will be contacted within 2 weeks. All candidates will be notified on receipt of their application. If you have not had a reply within 2 weeks, I would welcome an email and I WILL respond.