Scope of Function:
1) The transfer of existing Upstream Cell culture processes from client companies into process development and facilitating their transition into GMP production.
2) The design, development and scale up of new cGMP compliant mammalian cell culture and other upstream processes. These processes will consist of perfusion and stirred tank culture methods.
3) The resolution of technical problems and the monitoring of ongoing manufacturing campaigns.
Vice President of Process Development
1) Development of bioreactor manufacturing processes utilizing mammalian cell expression systems that meet GMP manufacturing requirements.
2) Development of batch or fed-batch cell culture processes.
3) Development of perfusion cell culture processes using various types of cell retention technologies.
4) Development of stirred tank cell culture processes.
5) Media development and optimization studies
6) Introduction of new processes and technologies into cGMP manufacturing.
7) Interaction with clients to facilitate the transfer of technical information between GBI and the client organization.
8) Good understanding of regulatory compliance and guidelines (e.g. FDA, EMEA, and ICH).
9) Development, planning and execution of pre-GMP scaled process runs/toxicology material.
10) Establish Bill of Materials list for new processes and maintenance of laboratory inventories and equipment.
11) Manage Process development scientists and Laboratory schedules to account for priority changes and project status. Interact with PD downstream to consolidate schedules
12) Record process development activities and results in appropriate notebooks.
13) Technology transfer of upstream processes into production and the training of production personnel. Coordination of activities and communication to assure efficient transfer of projects to manufacturing.
14) Writing and executing design input protocols and design output reports.
15) Writing SOPs and Batch records for newly implemented manufacturing processes.
16) Good verbal and written skills to communicate project status with clients and Project Management as needed.
17) Demonstration of ability to multi-task projects.
18) Interfacing with Sales and Marketing directly with perspective clients in order to facilitate sales.
Education and Skills Required:
Education: BS, MS or Ph.D. in Cell Biology, Biochemical Sciences or Biochemical Engineering
Experience: 5 (PhD) to 8 (BS) + years relevant industrial experience with a proven track record of accomplishments in the design, development and implementation of bioreactor and other cell culture processes. The utilization of molecular biology techniques as they pertain to cell line engineering, monoclonal antibody, and recombinant protein characterization for therapeutic use are a plus.
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. Candidate must possess excellent interpersonal and communication skills. Intermediate Computer skills are required.