Vacature CMC Lead Job

Purpose of the role:

The CMC lead will share the primary responsibility of ensuring the successful CMC development of Pharming's products and taking care that products are developed with high quality within the given timelines and budget.

Responsibilities:

• To help lead the CMC Operational Team. This cross-functional CMC Operational team is charged with managing the technology transfer and development/ manufacturing/testing/logistics CMC activities internally and at the C(D)MO/CLOs.
• To partner with R&D, Product Delivery, Quality, Regulatory and other departments if needed.
• To lead development activities including product development, process transfer and validation, analytical method transfers and life cycle management.
• Accountable for the scientific content of module 3 and ensure alignment with regulatory strategy
• In close collaboration with RA-CMC and SMEs develop strategies for the submission of Module 3 content to health authorities, including timelines, and risk management plans
• Provide responses to regulatory questions on Module 3 in close collaboration with RA-CMC and SMEs
• To oversee outsourced operations such that all technical, quality, cGMP and SHE compliance, and supply and business requirements are clearly understood, well documented and are consistently met.
• To provide a single point of accountability for identifying and managing timely resolution of operational and quality issues through the established C(D)MO/CLO site governance structure
• To prepare all operational (financial and timeline planning) activities needed with high quality, within the given timelines and within budget.
• To develop and negotiate Statements of Work (SOW) in collaboration with the CMC Operational Team, External Partnership Management, Procurement, Legal, and Finance.
• To identify potential C(D)MO/CLOs, prepare and evaluate Requests for Proposals (RFPs).
• To drive the CMC risk management process and prepare mitigating actions for the specific products.

Your profile

• 5 to 8 years of relevant (CMC) working experience in the pharma/biotech industry preferably both in a development and commercial production environment and minimal 2 years project management experience.
• Master's degree or PhD e.g. (Chemical) Engineering, (Bio)Pharmaceutical Sciences, (Bio)Chemistry, Life Science & Technology, Biology
• Sound knowledge and understanding of pharmaceutical development (variety of modalities including biologics, small molecule, process as well as analytical)
• Knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (e.g. EMA, FDA, Japan, ICH)
• Fluency in English, and ideally Dutch.

What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

• A highly competitive salary
• 8.33% holiday allowance (for NL)
• A minimum of 30 vacation days
• An excellent pension plan
• Commuting allowance

You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs.

Functie:	cmc lead
Startdatum:	23-5-2024
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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