OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.
To strengthen the growth of OM Pharma, we are currently looking for a Head of Process Development for our manufacturing plant in Geneva. In this function, you report to the Head of Industrial Development and manage a team of about 10 people. At this position you will successfully provide technical and strategic input for bio and pharmaceutical processes to ensure the maintenance, development, and optimization of high quality processes with emphasis on up-to-date technologies, while actively collaborating with other functions such as Manufacturing, Quality Management, Validation, Analytical Sciences, and Regulatory Affairs in different strategic projects.
Your main responsibilities are as follows:
- Lead a team of scientists/engineers/technicians focused on biotech 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
- Own the development activities for multiple projects in parallel (technical and R&D projects): understand process development based on GMP design considerations for commercial manufacturing, develop innovative solutions for biotech (UpStream to DownStream) and pharmaceutical manufacturing processes (bulk lyophilization, mixing and encapsulation).
- Provide technical direction to the team, manage technical risks ensuring successful projects management and delivery, obtain buy-in from client and provide solution to successful completion.
- Act as Project Manager or Project member for technical and R&D projects
- Support the current by coordinating and leading activities for investigations on process deviations on commercialized products i.e. Root Cause Analysis, and contribute to define and implement corrective/preventive actions (CAPA) in collaboration with Manufacturing, QA, RA-CMC and beyond.
- Serve as technical SME for QA and Manufacturing and in regulatory audit. Continually seeks opportunities to improve client satisfaction.
- Identify and collaborate with external service providers and a network of relevant expert to support development
- Ensure optimization of existing manufacturing processes to increase capacity and meet Operational Effectiveness and Quality requirements
- Supervise staff, define development designs, prepares and/or review protocol, study data, reports and presentation, provide constructive feedback and address any gap to ensure scientific validity and regulatory requirements
- Own and drive the implementation of standard development activities and harmonization
- Contribute to prepare and review documents in support of CMC regulatory teams 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 with strong team leadership and interpersonal skills bringing the following profile:
- PhD, Master, Engineer's Degree in pharmaceutical sciences
- At least 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
- 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.
Are you interested in this opportunity? Apply as soon as possible and join OM Pharma!