Our client is a global integrated biotech/pharmaceutical company, focusing on competitive development and commercialising innovative medicines that address unmet clinical needs in ophthalmology.
They’re current looking for a Head CMC.
Reporting directly to the CEO, this Head CMC is responsible for CMC-related activities across the portfolio including process chemistry, route development, chemical manufacturing, (pre)formulation & manufacture and supply of clinical trials materials.
- Overall responsibility for all drug substance & drug product activities from preclinical development through clinical supplies for Phase III;
- Identification selection & management of Contract Manufacturing Organisations (CMO’s) for process optimisation, cGMP and supply of Drug Substance (API) and Drug Product (DP);
- Development of strategy & DOE for optimisation and control quality of bulk API, DP using CROs & CMOs;
- Formulation design / development for clinical programs;
- Ensure & manage global supply, management of supply chain & logistics in support of clinical studies; negotiate supply agremeents, set technical & business strategies;
- Compliance: ensury quality agreements are in place, manufacturing process & product specification of clinical trial materials are appropriate, performed in compliance with in/external guidelines;
- Outsourcing: ensure contractors are selected for contracting out GMP, GLP, GCP + ensure approved contracts & agreements + approve changes to the scope of work contracted out.
- PhD in relevant scientific or technical discipline;
- Substantial experience in managing CROs CMOs for manufacture of APIs & DP;
- Experience with projects in clinical development;
- Experience in process development & commercial manufacturing for both drug product & drug substance;
- Ability to identify & resolve critical issues;
- Experience in implementing technical, strategic & ops plans;
- Able to coach and motivate others;
- Ability to plan and adapt the organisation for short, medium and long term development;
- A sense of responsibility towards achieving the company’s objectives, while respecting its vision and values;
- Long-term and business-minded thinking;
- Willing to travel (EU).
Plaats tewerkstelling: Leuven
If you’re interested in this position and/or you need further information, you can contact Katrien Lefevere – Managing Consultant – on her mobile +32 473 512 891 or send your detailed resume to firstname.lastname@example.org
Embark – HR Consultancy & Recruitment Services www.embark.be
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