PD-USP Senior Process Development Scientist - Cell Culture Development |
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Scope of Function:
Reports to: COO
Specific Duties:
Education, Experience Required:
Education:
Experience:
Interacts With:
- 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