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Hobson Prior is working with a clinical-stage drug discovery and development discovering organisation who advance pioneering therapies to advance the standard of treatments for serious infectious diseases. Our client is looking for a CMC Director to join them on a permanent basis.
Delivery and execution of the drug product formulation strategy across the drug product life cycle and with emphasis in late development stages, registration and validation.
Responsible for all product development activities aspects related to the dosage form whilst working in partnership with external and internal stakeholders.
Builds product development and supply capabilities utilising science-driven, phase-appropriate, and risk-based development activities and support the delivery of appropriate control strategies for the associated products.
Fully manages third-party partnership (CDMOs) and collaborations for drug product development cultivating strong working relationships and a commitment to quality.
Identifies and recommends the best contract development and manufacturing partner for each project.
Is the subject matter expert and author and/or reviewer for relevant sections of CMC documentation in support of CTA/INDs, IMPDs and e-CTD submissions as well as regulatory amendments, and scientific briefing documents.
Analyses data and provides scientific explanations and insight for project work.
Ensures that the projects are being run within budget according to agreed timelines and that appropriate decisions are made at each stage of the project.
Works alongside other functions on the broader technical development strategy and leadership decisions with the wider CMC group and, where necessary, the Project Team.
Supports the strategic decisions made in consultation with the SVP CMC and Supply Chain and other key senior leaders to advance drug product manufacturing and pipeline projects.
Builds strong working relationships with other functions, including Finance, IP, Legal, Business Development and HR to ensure the optimal environment for delivery within the Product Development and Supply section.
Presents regularly to the internal senior leadership team and provides timely provision of data and documentation reports to support intellectual property filings and regulatory submissions.
Has an entrepreneurial and collaborative attitude.
Self-motivated with a high level of attention to detail.
Possesses excellent communication & interpersonal skills with experience of managing and presenting complex scientific data.
PhD in a relevant scientific discipline or equivalent hands on experience.
Proven leadership experience (10+ years) in the biotechnology or pharmaceutical industry with demonstrated expertise of formulation development and drug product manufacturing for small molecules in a wide range of dosage forms (oral solid, solution, suspensions, sterile etc.).
Prior experience in working in an outsourcing business model and success in development drug products via leading CDMO relationships.
Experience in pharmaceutical drug product formulation, pre-formulation and process development.
Knowledge in pharmaceutical development concepts as outlined in ICH Q8 (R2) as well as other applicable ICH and regulatory guidelines.
Significant experience with scaling up, process characterisation, process validation and transfer of manufacturing processes to GMP manufacturing sites.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
$85000 - $90000 per annum
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