Job Description

Are you an experienced Scientist with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Scientist to work at their company in Montgomery County, PA.

Primary Responsibilities/Accountabilities:

• Seeking candidates for a position within our company's research laboratories Biologics Pilot Plant (BPP) Process Operations Team. This person will 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. There may be opportunities to cross over and contribute to manufacturing activities in bulk upstream/downstream as a support role. A working comprehension of regulatory guidelines governing GMP manufacture is essential.
• The candidate will work in matrixed teams with process development, facility engineering, quality engineering, GMP compliance, and safety groups. Some overtime, including weekends and occasional second and third shift work, will be required. Assignments include all aspects of preparation, execution, and closeout of a GMP campaign.
• 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. This person will lead manufacturing steps and must be able to plan, communicate, and lead small groups to achieve tactical objectives.

Qualifications:

• Bachelor’s or Master’s degree in Chemical Engineering or Biological Sciences with 1-3 years of relevant experience.
• GMP manufacturing and/or process development cell culture activities (mammalian, bacterial)
• 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

Preferred:

• 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

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