Director of Manufacturing, Control

2 maanden geleden

Leiden, Nederland Pharming Group Voltijd

**About Pharming Group N.V.**
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) 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 and biologics. Pharming is headquartered in Leiden, the 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 Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) 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 and biologics. Pharming is headquartered in Leiden, the 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.
thway forward to meet our strategic goals and objectives.

**Purpose of the Role**:
The Director of Manufacturing, Control & Support (MCS) plays a crucial role in optimizing and coordinating commercial production and analytical processes. This position involves empowering cross-functional teams and external partners to drive continuous process improvements and ensure seamless operations. The Director oversees post-filing activities, including re-validation and stability testing, by fostering collaboration and ownership across teams. This approach ensures that Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs) consistently meet commercial requirements efficiently. Acting as a facilitator and process owner, the Director supports the organization’s strategic transition to a matrix structure, where functional excellence

Areas of responsibility
- Empower and coach the MCS team to take ownership of process improvements and operational efficiency, ensuring that production and quality control processes run smoothly at CMOs/CLOs.
- Oversee and optimize process workflows during commercial production, including re-validation, issue resolution (deviations/CAPAs), and support for audits, in collaboration with the cross-functional teams (R&D, CMC).
- Ensure efficient transfer activities for commercial product manufacturing and analytical testing to new CMOs/CLOs, fostering collaboration between stakeholders to maintain seamless operations.
- Trend and analyse process and analytical data for continuous improvement of commercial products, empowering the team to identify and implement improvements in collaboration with cross-functional partners.
- Lead and support process optimization initiatives across manufacturing, analytical testing, and transport validation in partnership with internal stakeholders, ensuring a focus on operational excellence rather than product-level decision-making.
- Facilitate process lifecycle management through collaboration with CMC and other departments, ensuring that processes are continuously optimized and scalable for future needs.
- Supporting regulatory submissions by reviewing documents, ensuring alignment with evolving operational needs and compliance standards.
- Translate company goals into a cohesive manufacturing and analytical strategy, collaborating with R&D, CMC, and other departments to align resources and processes.
- Ensure adequate resourcing for MCS functions, guiding teams to execute compound programs and participate in cross-departmental projects in a matrix structure.
- Prepare and manage the departmental budget, ensuring process improvements and activities align with budget and project timelines.
- Represent MCS in cross-functional and companywide initiatives, acting as a strategic enabler to ensure process improvements and cross-functional efficiency.
- Stay updated on relevant technologies and industry developments, encouraging a culture of continuous learning and adaptation within the team.

**Knowledge**:

- Master's degree or PhD in Chemical Engineering, (Bio)Pharmaceutical Sciences, Chemistry, or related field.
- Deep understanding of pharmaceutical manufacturing, validation, and lifecycle management, with a focus on process optimization, commercial production, and quality testing.
- Strong knowledge of regulatory guidelines (cGMPs, FDA, EMA) and the ability to align operational processes with these standards.
- Strong verbal and written communication skills in English (Dutch a plus) to effectively coach, collaborate, and support team empowerment.

**Experience**:

- Minimum of 10 years of experience in the pharmaceutical/biotech industry with at least 5 years of leadership experience focused on managing processes, teams, and cross-functional collaboration (commercial prod

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