Manufacturing Sciences and Technology Scientist
Thörishaus, Bern, Switzerland
PaxVax is looking to recruit an experienced professional into the role of Manufacturing Sciences and Technology Scientist. This position is responsible for being the main technical support person for manufacturing processes in the area of Virus like Particle production/Mammalian Cell expression. This person has experience with GMP manufacturing processes and will perform process transfer from PaxVax Technical Development Unit. The individual is a subject matter expert for various aspects in process understanding, design and analytics and is expected to question and solve on tasks when clarification or greater technical expertise is required. This individual may provide immediate supervision or assign tasks to a unit or group of employees.
- Drive process development, process scale up and manufacturing of clinical trial materials for late stage clinical trials
- GMP manufacturing support. Current Good Manufacturing Practices, US / EU regulations.
- Performs all functions associated with process transfer and process support, e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, author / review planned deviations and change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, perform activities for lot release (assess deviations and process changes).
- May provide guidance on process transfer and support activities to junior members of the team.
- Responsible for Deviation and Change Management
APPLY FOR THIS JOB
- Advanced knowledge of cell biology, cell culture, scale up and mass transfer, bioreactor operation, filtration and intermediate knowledge of statistical data analysis (JMP preferred)
- In depth knowledge of large scale manufacturing, current Good Manufacturing Practices and US/EU regulations.
- Experienced in aseptic technique and mammalian cell culture;
- Advanced knowledge of chromatography and UF/DF
- Experience with upstream processing using human cell lines
- Strong communication, technical writing, organizational and interpersonal skills; Strong computer skills (including Word, Excel, Outlook and PowerPoint.)
- Demonstrates critical thinking skills in problem solving and decision making; Attention to detail and high level of accuracy; The capacity to motivate and encourage others
- MSc in biological sciences, PhD preferred
- Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.
- Attention to detail and good investigation, problem solving and organizational skills
- Excellent written (especially technical writing) and verbal communication skills in german and english
- Ability to travel