Head of Cell culture
Scope of Function:
1) The transfer of existing Upstream Cell culture process from client companies into process development and facilitating its transition into GMP production.
2) The development and scale up of new cGMP compliant mammalian cell culture and other upstream process
3) The resolution of technical problems and the monitoring of ongoing manufacturing campaigns.
1) All upstream development activities. Demonstrative experience in the development of bioreactor manufacturing processes utilizing mammalian cell expression systems (including deep tank processes using fed-batch techniques) and meet GMP manufacturing requirements.
2) Introduce new technologies into cGMP manufacturing
3) Perform in-process assays as required such as Western blotting, ELISA, SDS PAGE, IEF, HPLC and other protein assays.
4) Develop, plan and execute pre-GMP scaled process runs, establish Bill Of Materials list for process
5) Maintain laboratory inventories and equipment.
6) Oversee Process Development technicians as needed
7) Record process development activities and results in appropriate notebooks.
8) Transfer and coordinate upstream processes into production and the training of production personnel.
9) Write and execute design input protocols and design output reports.
10) Writing SOPs and Batch records for newly implemented manufacturing processes.
11) Coordination of activities and communication to assure efficient transfer of projects to manufacturing.
12) Communication of project status with clients and Project Management as needed
13) Multi-task multiple projects
14) Estimate Technical aspects of processes for Sales and marketing as needed
Education and Skills required:
Education: BS, MS. Ph.D. in biological or biochemical sciences
Experience: BS 6+ years process development experience with proven track record of accomplishments in the field. MS 4+ years relevant laboratory and industrial experience with proven track record of accomplishments in the field. Ph.D. 0 + years industrial experience. Experience in GMP manufacturing is desireable.
Skills: Must be able to work independently with minimum direction. Must be able to develop and implement to completion experimental protocols as they pertain to the duties listed above. Good Computer skills.
Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Project Management, Materials Management, Sales and Marketing, Purchasing, and Client
|Goodwin Biotechnology Inc.|
State or Province