Vacancy caducado!
- Lead projects associated with establishing robust and compliant manufacturing processes through defining the manufacturing process and associated control strategy
- Responsible for preparation and review of technical documents such as batch records, sampling plans, process related and analytical method SOPs, risk assessments, study protocols, and technical reports and/or relevant sections for regulatory submission files
- Help with first line technical support to manufacturing in compliance with relevant instructions and quality requirements
- Lead process characterization, scale up, process optimization, and process validation
- Use scientifically sound rational and statistical tools for data analysis, contribute to enhancing process understanding and identifying key sources of variability and root causes of product and process failures
- Help change review and implementation, quality investigations, and CAPAs in cross-functional teams
- Participate in the definition and selection of equipment by providing input to User Requirement Specifications (URS) and creating associated procedures
- Help process equipment FAT, SAT, and on-site qualification activities
- Provide guidance and training to associates across sites and functions as relates to assigned projects and consistent with the quality governance
- Represent the CMC Development function in project team meetings
- Bachelor's in biochemistry, chemical engineering, microbiology, biotechnology or related discipline with five years of experience in the biotechnology industry; or Masters/PhD with three years of experience in the biotechnology industry or equivalent work experience
- Experience with mammalian cell /viral culture, bioreactor operations, cell separation and virus purification techniques
- Project management experience
- Experience in experimental design and statistical analysis methodology
- Experience with projects in clinical development e.g., Phase 1 through Phase 3
- Biopharmaceutical development experience specifically in viral vaccines and/or monoclonal antibodies development, upstream, downstream, and filling strongly preferred
- Experience with cGMP manufacturing and regulatory submissions preferred
Vacancy caducado!