PD-USP Senior Process Development Scientist - Cell Culture Development

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Scope of Function: 

• ​The transfer of existing Upstream Cell culture process from client companies into process development and facilitating its transition into GMP production
• The development and scale up of new cGMP compliant mammalian cell culture and other upstream process
• The resolution of technical problems and the monitoring of ongoing manufacturing campaigns

Reports to: COO

Specific Duties:

• 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
• Introduce new technologies into cGMP manufacturing
• Perform in-process assays as required such as Western blotting, ELISA, SDS PAGE, IEF, HPLC and other protein assays
• Develop, plan and execute pre-GMP scaled process runs, establish Bill Of Materials list for process
• Maintain laboratory inventories and equipment
• Oversee Process Development technicians as needed
• Record process development activities and results in appropriate notebooks
• Transfer and coordinate upstream processes into production and the training of production personnel
• Write and execute design input protocols and design output reports
• Writing SOPs and Batch records for newly implemented manufacturing processes
• Coordination of activities and communication to assure efficient transfer of projects to manufacturing
• Communication of project status with clients and Project Management as needed
• Multi-task multiple projects
• Estimate technical aspects of processes for sales and marketing as needed

Education, Experience Required:

Education:

• BS, MS, PhD in biological or biochemical sciences

Experience:

• A BS degree with process development experience with proven track record of accomplishments in the field
• An MS degree with 6+ years relevant laboratory and industrial experience with proven track record of accomplishments in the field
• A PhD with 0+ years industrial experience (new PhD with post-doc experience a plus)
• Experience in GMP manufacturing is desirable
• 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

​Interacts With: 

• Quality Assurance
• Quality Control
• Regulatory Affairs
• Manufacturing
• Project Management
• Materials Management
• Sales and Marketing
• Purchasing
• Clients