Director, Product Development & Technical Affairs – ProTA Therapeutics Pty Ltd

ProTA Therapeutics is a newly established Australian private company developing immunotherapy based treatments for food allergy. The company’s lead product based on technology spun out of the Murdoch Childrens Research Institute, is under development as a treatment for the most common cause of life-threatening anaphylaxis, peanut allergy.

The Role

The company seeks to build its development capabilities to manage the transition from Proof of Concept to Phase III clinical development and cGMP manufacturing. The successful candidate will lead, direct and manage the product development process within the company, working closely with partners, regulatory consultants, CRO and CMO companies.  A hands on approach is required to develop a CMC package, a regulatory strategy to guide clinical development and documentation for the FDA, TGA and European regulatory bodies.

Duties and Responsibilities
  • Lead all CMC related activities to drive development of company
    • Generate Specifications for Raw materials, In-Process materials, and Finish Drug product
    • Ensure that methods of manufacture are suitably validated and manufacturing facilities are in compliance with PIC’s GMP requirements
    • Ensure suitability and qualification/validation of release specifications and analytical methods
    • Review batch records and COA to ensure product meets efficacy, safety and purity requirements
    • Manage external consultants and lead the preparation of CMC regulatory package for the FDA and EMA.
  • Manage external service providers, including research services, CRO’s and CMO’s
  • Work with relevant stakeholders (internal and external) to prepare technical documents and reports and to support preparation of clinical study documentation as required.
  • Manage regulatory agency interactions as appropriate including preparation of briefing packs and responses to agency questions.
Pre-Requisite Qualifications and Capabilities
  • A Bachelor degree in a related life sciences discipline, preferably with post graduate qualifications
  • A minimum of 5 years’ management experience in pharmaceutical or biotechnology industries.
  • At least 5 years experience in product development within the pharmaceutical or biotechnical
  • Proven management experience with strong leadership and motivational
  • Exceptional organizational skills and project management capability.
  • Excellent oral and written communication skills

The successful applicant will be a key member of the Executive Management team, working both independently and as part of a small multidisciplinary team. The ability to shift effortlessly from strategic planning and leadership functions, to hands on performance will be required for success in this role. A capacity to communicate with individuals across disciplines and at all levels in the organisation are essential, as well as the ability to work harmoniously within a small team environment.

Experience with production of pharmaceutical products in a laboratory or manufacturing operation that complies with cGLP/cGMP would be highly regarded, as would knowledge of international regulatory and clinical requirements, including FDA, TGA and EMA.

Applications

For a confidential discussion about this role, or to obtain a position description, please contact:
Dr. Suzanne Lipe, CEO ProTA Therapeutics
suzanne.lipe@protatherapeutics.com

Applicants will be required to email their resume and covering letter providing relevant key skills and experience, prior to the closing date of 27 April, 2017.

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