Job Reference: J5634586
Updated On: 22/03/2021
Status: Open to Applications
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Role OverviewWe are currently looking for an Associate Director CMC to join an innovative biopharmaceutical company based in Cambridgeshire. As the Associate Director CMC you will be responsible for leading the Process Development Group within the preclinical development department, focused on building a new class of therapeutic medicines.
Key Duties and ResponsibilitiesYour duties as the Associate Director CMC will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for developing in-house fermentation processes and providing support for upstream and downstream method development and optimisation.
2. Your responsibilities will include directly liaising with external CDMOs to co-ordinate the outsourced process development activities, as well as supporting the process and assay transfer.
3. As the Associate Director CMC, you will co-ordinate lyophilisation development studies, as well as incorporating in-house capabilities, and will work closely with the assay development team to develop assays designed to assess microbial cell quality.
4. It will be important to maintain an awareness of latest technologies and equipment for incorporation into company labs.
Role RequirementsTo be successful in your application to this exciting opportunity as the Associate Director CMC we are looking to identify the following on your profile and past history:
1. Relevant degree (PhD preferable) within a Microbiology or Bioprocess Engineering discipline along with extensive experience within Fermentation is essential.
2. Proven industry experience in a bioprocess development environment working with bench scale bioreactors, ideally in a bacteriology setting, is essential.
3. A working knowledge and practical experience with Design of Experiment or Quality by Design will be highly desirable.
Key Words: Fermentation | Group Leader | Process Development | Bioprocess | Upstream | DoE | Design of Experiment | Quality by Design | Biotechnology | Biopharmaceutical | Microbial | Process Development | Downstream | Bacteria | GMP | Ferment | Freeze-Drying | Lyophilisation | Research
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