Position: Downstream Tech Transfer, Associate Scientist II
Location: King of Prussia (Onsite)
Company: SK Pharmteco
The Associate Scientist II, Downstream Tech Transfer (PD/Tech Transfer) will report to the Associate Director of Tech Transfer and will have responsibilities supporting the downstream process development technology transfer activities for viral vector pilot and GMP manufacturing campaigns. Candidates may have experience in downstream purification, viral vector production, scale up, Tech Transfer, GxP documentation, and technical report authoring and review. Experience in project management and Microsoft visio is a plus, but not required.
Responsibilities:
- Work closely with process development scientist and/or client in process knowledge transfer to scale-up process for pilot scale under supervision of manager
- Support Process Fit to Plant evaluation
- Author protocols to support pilot-scale manufacturing campaign.
- As an Associate Scientist II, some degree of independent execution is expected.
- Provide planning and logistics support for pilot scale execution
- Provide hands-on and technical support during execution of pilot-scale execution.
- Author knowledge transfer documentation for GMP manufacture (e.g., bill of materials, process flow diagrams, and sample plans)
- Partner with manufacturing, engineering, and quality to establish process-specific batch records for GMP manufacture.
- Collaborate with process development scientists and manufacturing to establish technology transfer plan and perform technical risk assessment for the product/process introduction to the GMP facility.
- Provide technical support for process-related issues or investigations.
- Provide scientific/engineering support for technology transfer and manufacturing of viral vectors
Requirements:
- B.S. in engineering, life sciences, or related field, plus 1-3 years in relevant academic or industry technical experience.
- M.S. in engineering, life sciences, or related field, plus 1-2 years in relevant academic or industry technical experience.
- Hands-on experience with common downstream pilot equipment and operations (i.e., Depth Filtration, Akta Process, Ultracentrifugation, UF/DF, etc.) and ability to train junior staff
- Ability to follow procedures with attention to detail, and successfully execute experiments at the bench
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Demonstrated ability to maintain detailed execution records and perform data analysis
- Knowledge or experience with gene therapy manufacturing in the biotech industry is preferred
- Strong communication skills (e.g., clear and concise) and a team player
- Strong time and project management skills
- Critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
- Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
- Takes ownership of the assigned project, consulting with management and peers
- Able to understand and interpret data/information and its practical application
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 30 pounds at times.
- Standing/working in a lab setting for more than (4) hours when needed.
