What are the responsibilities and job description for the Scientist II position at inSync Staffing?
Scientist II
53.45 / hr
Onsite : West Point, PA
1 year assignment
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, leading unit operations on either upstream or downstream steps, and contributing to manufacturing activities in the other discipline as needed. 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 upstream unit operations such as mammalian / yeast / bacterial cell expansion, virus / protein expression in single-use disposable systems and / or stainless-steel bioreactors.
Performing 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.
Quals
Bachelor s or Master s degree in Chemical Engineering or Biological Sciences with 4-8 years of relevant experience.
Required Experience and Skills :
GMP manufacturing and / or process development activities of biologics, or vaccines
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 one or more process unit operations
Experience leading small teams in a matrixed organization
Benefits : (employee contribution)
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Salary : $53