Upstream Scientist

Upstream Scientist at Net2Source (N2S) Upstream Scientist at Net2Source (N2S) in MONTGOMERYVILLE, Pennsylvania Posted in 1 day ago.

Type:

full-time

Job Description:

Title:

Scientist I -

Upstream/ GMP Biologics Location:

West Point, PA 19486 100% onsite

Duration:

12 months contract

Shift:

Some overtime, including weekends and occasional second and third shift work, will be required Position Summary

• Work on pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of biologic and vaccine bulk clinical supplies (focus on cell banks), leading cell expansion unit operations
• May contribute to manufacturing activities in bulk upstream/downstream as a support role
• Work in matrixed teams with process development, facility engineering, quality engineering, GMP compliance, and safety groups
• Assignments include all aspects of preparation, execution, and closeout of a GMP campaign Responsibilities
• Executing cell bank manufacturing and upstream unit operations such as mammalian/yeast/bacterial cell expansion, virus/protein expression in single-use disposable systems and/or stainless-steel bioreactors
• Secondary role to support downstream operations such as normal flow filtration, tangential flow filtration, homogenization, lyophilization, chromatography, and centrifugation
• Preparing critical documents including standard operating procedures, batch records
• Completing production readiness activities such as equipment cleaning & steam sanitization
• Evaluating and integrating innovative technology/process equipment fit
• Developing equipment specifications & participating in start-up activities
• Working in a multi-disciplinary project team environment
• Troubleshooting process unit operations
• Leading process unit operation teams
• Lead manufacturing steps and plan, communicate, and lead small groups to achieve tactical objectives

Education :

• Bachelor's or Master's degree in Chemical Engineering or Biological Sciences with 1-3 years of relevant experience

Experience :

• GMP manufacturing and/or process development cell culture activities (mammalian, bacterial)

Skills :

• Teamwork and collaboration
• Working knowledge of cGMP, Quality Systems, and safety for operations
• Self-motivated with the ability to work in a fast-paced and dynamic setting
• Organizational, problem-solving, and project management skills
• Technical background in cell culture unit operations (vial thaw, shake flasks, cell stacks, flasks, incubation, harvest/centrifugation, vial filling, freeze, thaw/recovery)
• Experience leading small teams in a matrixed organization