Scientist I

The job description is provided below for your convenience.

Req Number: MSD1JP00002888

Req Title: Scientist I

Client: A major pharma company

Work Address: West Point, Pennsylvania

Duration: 12 M

Hours per Week: 40

Position Summary:

• 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.

Primary 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. This person will lead manufacturing steps and must be able to plan, communicate, and lead small groups to achieve tactical objectives.

Qualifications:

Education: Bachelor’s or Master’s degree in Chemical Engineering or Biological Sciences with 1-3 years of relevant experience.

Required Experience and Skills:

• 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 Experience and Skills:

• 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.