Associate Cmc Lead

7 maanden geleden

Leiden, Nederland Pharming Group Voltijd

**About Pharming**
Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

**Our Culture**
Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

**Purpose of the role**:
The Associate CMC lead will, together with the CMC Lead, 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 mínimal 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. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”.

Also important We truly value a healthy life-work balance with a lot of flexibility.

Does this sound like you and do you want to join our team? Then we'd love to hear from you

We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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