Advanced Biotechnology Manufacturing Specialist
Vor 6 Tagen
We are a leading pharmaceutical company with a presence in over 60 countries and a team of approximately 134,000 employees. Our mission is to bring innovative ideas, products, and services to advance the health and well-being of people worldwide.
About UsAs a global biopharmaceutical company, we are dedicated to discovering, developing, manufacturing, and marketing products that combat major threats to global health. Our Bern site serves as a center of expertise for development and manufacturing of innovative cell-based viral and bacterial vaccines, as well as bacterial based therapeutic products.
Job DescriptionThis position will support a routine GMP manufacturing process with a focus on downstream process steps (chromatography, diafiltration/ultrafiltration). The successful candidate will be responsible for:
- SUPPORTING ROUTINE GMP MANUFACTURING PROCESS
- HELPING IN TROUBLE SHOOTING AND PROCESS IMPROVEMENTS
- DATA VERIFICATION AND TRENDING
- WRITING OF SOP's (FIRST DRAFT MBR'S, WORKINSTRUCTIONS, EQUIPMENT HANDLING)
- TRAINING OPERATORS ON THOSE DOCUMENTS
- WRITING OF REPORTS (TECHTRANSFER/CAMPAIGN) AND TECHNICAL DOCUMENTS LIKE RISK ASSESSMENTS
- SERVICE AS SUBJECT MATTER EXPERT FOR QUALITY ISSUES, ROOT CAUSE ANALYSIS, AND INVESTIGATION
- INITIATING AND IMPLEMENTING CHANGE CONTROLS
To be considered for this role, you should have:
- Masters or Bachelors degree in Bio-Engineering / Biotechnology / Biology / Biochemistry
- Experience in GMP compliant biotechnological manufacturing or development
- Experience in chromatography and DF/UF
- EXCELLENT PROBLEM SOLVING AND ANALYTICAL CAPABILITIES
- KNOWLEDGE IN STATISTIC
- TEAM PLAYER WITH EXCELLENT INTERPERSONAL COMMUNICATION SKILLS
- CAPACITY TO COMMUNICATE FLUENTLY IN ENGLISH AND GERMAN
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