Head Process Development – Vifor Pharma – Meyrin, GE

Your main missions are:

• Manage teams of bio and pharmaceutical processes development: develop the team, develop people, ensure reliability, meet deadlines, make decision in a timely manner, promote team cohesion and ownership, ensure operational effectiveness
• Closely manage budget of the team (OPEX, CAPEX, FTE): budget establishment, follow-up, accrual management, forecast
• Act as Project Manager or Project member for technical and pipeline projects of the site
• Lead process development for technical projects activities: development of biotech manufacturing processes (UpStream to DownStream), pharmaceutical manufacturing processes (bulk lyophilization, mixing, encapsulation and packaging) and development of cleaning processes (biotech and pharma)
• Coordinate and lead activities for investigations on process deviations i.e. Root Cause Analysis, and the implementation of corrective/preventive actions (CAPA) in collaboration with Manufacturing QA, RA-CMC and beyond
• Ensure optimization and evolution of existing processes to meet Manufacturing Operational Effectiveness and Quality requirements
• Supervise staff, define development designs, review and approve protocol, study data and reports generated by the teams to ensure scientific validity and regulatory requirements
• Identify and collaborate with external service providers and a network of relevant expert to support development
• Contribute to prepare and review documents in support of CMC regulatory filings and addressing queries from HA’s related to manufacturing process development
• Manage HA’s inspections and audits for process development activities

For this role, we are looking for a reliable, solution-oriented and business-driven experienced leader, bringing the following profile:

• PhD, Master, Engineer’s Degree in pharmaceutical sciences

• 10 years of experience in product / process biotech development in the pharmaceutical industry in GMP environment

• Extensive experience in biotechnology manufacturing process development, from pilot to industrial scale, scale-down, scale-up, in

• Proven experience in Team Management,

• Highly developed Leadership & Decision making skills

• Cross functional skills (Manufacturing, QM, RA)

• Project management

• Proven experience in a GMP environment

• Fluent in French and English both in oral and written conversation.

To be successful in this role, we are looking for an experienced leader and mature process development professional. You hold extensive people management experience and truly enjoy coaching your teams and help them reaching success. You describe yourself as solution oriented, flexible and able to take initiative to move things forward. Thanks to your communication skills, you easily develop new relationships and feel comfortable in a situation where you need to influence and convince others, internal and external stakeholders. Furthermore, your strategic thinking enable you to examine and understand issues from multiple points of view and propose corrective actions with a pragmatic and proactive approach.