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Head of Manufacturing
Strategic position as Head of Manufacturing in a scale-up company
Possible evolution towards a C-level position
About Our Client
Our client is a drug discovery and development company that has recently received the agreement to accelerate the development of its protein by conducting the Phase 3 of the clinical trial.
The Head of Manufacturing:
- defines and implements CMC strategies, product manufacturing and supply plans (from raw materials to finished product) to support clinical development.
- operates in a clear, creative and effective way so as to complete tasks on time and with the required quality
Depending on experience, may develop into a C-level position.
- Lead process development, product manufacturing for clinical and market supply for the Company's Clinical development
- Define and implement CMC strategies in manufacturing process transfer to the Company's CMO under GMP
- Leads and coordinates analytical methods and processes under GMP
- Lead key strategic CMC matters so as to:
* Identify and resolve critical CMC development issues;
* Identify and resolve critical CMC risks;
* Proactively communicates relevant CMC information to all stakeholders.
- Anticipates and reacts to major technology advances to ensure the maintenance and improvement of the Company's CMC capabilities
- Establish technical standards and ensure adherence to them for product development and company operations
- Responsible for, and coordinates, all interactions with all CMC contract manufacturing organizations and contract research organizations
The Successful Applicant
- Doctorate degree in Life Sciences or Chemical Engineering;
- At least 10 years of experience in the manufacturing of recombinant proteins under GMP;
- Profound knowledge of GMP regulations;
- Experience in market supply planning;
- Drug development experience and project management skills are a must;
- Hands-on approach;
- Team player;
- Languages: English is a must; French and a third language are assets.
What's on Offer
Fix salary + bonuses