Reporting to Biosynthesis Manager, the general role of the position is the technical and operational management of production and documentary activities related to extraction and purification from fermentation processes, all of them ensuring compliance with GMP regulations.
- HHRR organization and training according to process requirements.
- Guarantee the availability in time and correct state of material resources (raw materials, reagents, equipment and facilities) for the processes performance.
- Ensure that manufacturing plans are met and obtaining product within especifications.
- Correct management of incidences and troubleshouting.
- Manufacturing document edition, control, revision and reporting.
- Process optimization and specialized DSP support for new projects development.
- Preparation of activity reports as required.
- DSP KPIs tracking and managing for goals compliance.
- According to EHS company policies and procedures, responsible for compliance within DSP operations.
- Collaborate with the rest of departments as required.
Candidates will need to show evidence of the following :
- Preferably hold a degree in Chemical Engineering – Bioprocesses.
- Four years minimum of previous working experience in industrial downstream from large scale fermentation (API-HPAPI) and in specialized downstream involving cells extraction/purification from other bioprocesses (therapeutic proteins, biogenerics, …)
- High english level.
- Analytical techniques knowledge and handling (HPLC, GC, FT-IR, KF titration).
- GMP knowledge and experience.
- EHS training valuable.
- Extremely organised and ability to work under pressure with multiple projects to strict on-going deadlines.
- Excellent communication skills (oral and written) and interpesonal skills.