Posted 1 year ago
Key responsibilities:
- Coordinate outsourced activities, ensuring CDMOs accountability for the quality of their products and documentation as well as on-time delivery of the biotech APIs
- Plan and coordinate team meetings with CDMOs and follow-on with actions
- Review technical proposals from CDMOs
- Review external documentation (protocols, reports, quotations, batch reports…)
- Perform data analysis, data aggregation and reporting
- Contribute to the preparation of CMC and regulatory documentation for biotech APIs
- Ensure that external activities adhere to GMP, regulatory guidelines, standard processes and SOPs, where applicable
- Propose process optimizations and recommend technologies in relation to bioprocessing
- Assist with requests from Health Authorities
- Keep aware of current scientific and regulatory knowledge as well as main actors in the field of biological products
- Contribute to the development of internal expertise for bioconjugates
Your profile:
- Engineering Degree (Biotechnology, Biology or Biochemistry)
- Must have >7 years of experience in a Pharmaceutical or Biotech Manufacturing organizationin various stages of project development
- Comprehensive understanding of the global development of biologicals from preclinical to late-stage clinical development
- Direct experience in the manufacture of biotech products such as Antibodies and Antibody Drug Conjugates
- Comprehensive understanding of CMC and regulatory aspects for biotech products
- Knowledge of analytical requirements for biotech products
- Expertise in working with sub-contractors and ability to coordinate external activities
- Strong communication, team spirit and organizational skills
- Direct management of cross-functional teams is a plus
- English fluent spoken and written is mandatory
Job Features
| Job Category | TECHNICAL R&D |