Manager / Sr Manager Lyophilization Expert
Our team provides advanced technical troubleshooting to manufacturing sites all over the world.
In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements. Complex technologies and processes are our area of expertise. We are the ambassadors of technology standardization and Next Gen technology. Globally located, connecting and facilitating connections inside and outside Pfizer is second nature.
The main focus of the position of Lyophilization Process Expert is to provide advanced technical support for commercial aseptic drug product lyophilization manufacturing. The incumbent will be an expert in lyophilization cycle design, lyophilization manufacturing operations management and how it affects product quality and manufacturing efficiency. Products include vaccines, MAbs, peptides, antibiotics and small molecules.
We believe in teamwork. The description below is indicative, but the results of the team are the main priority.
* Provide advanced technical support for lyophilization and lyophilized products for aseptic drug products manufactured at Pfizer internal and external sites
* Lead complex investigations, regulatory responses and improvement projects
* Key member of implementation team for Pfizer's World Class Lyophilization initiative
* Participate in cross functional teams to identify, evaluate and develop innovative solutions to manufacturing processes and drug product issues
* Lead characterization of commercial lyophilizers and/or mathematical modeling
* Contributing member of the Pfizer Lyophilization Network, a global interest group for those working in lyophilization in PGS, R&D, Regulatory, and Quality organizations.
* Provide training on lyophilization in formal and informal settings. The key audiences are each site's technical services groups, quality operations and operations support.
* Assist with development, assessment and implementation of process analytical technologies.
* Advise on technical transfer and scale-up
* May conduct small-scale lyophilization experiments and/or direct production-scale experimental trials
* Review and provide guidance for manufacturing processes under development by research and development
* Drive innovation in the aseptic drug product lyophilization manufacturing space
* Able to respond quickly and sometimes travel on short notice
* Bachelor's degree or above in engineering or science
* Expertise in aseptic manufacturing and lyophilization
* Utilization of verbal and written communication skills to effectively communicate complex ideas and solutions across multiple levels of the Pfizer Organization
* Strong analytical thinking and problem solving ability to facilitate resolution of both business and technical issues
* Well-developed interpersonal skills (leadership, integrity, team orientation, flexibility and creativity)
* Respects commitments and procedures
* Discipline in project execution
The position requires up to 25% of international travel.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Belgium - Puurs