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Scientist
Job Description
The Scientist role in Commercial Process Development will be part of the global method implementation team responsible for method transfer and method validation to Quality Control for pivotal and late stage programs.
The role will provide technical support for critical large projects. Strong familiarity with the following method platforms is highly preferred: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. Protocol and report authoring according to regulatory and industry guidelines (i.e., ICH) and data analysis will be a core activity in this role. This individual may support clinical and commercial locations throughout the company under the guidance of project leads.
Basic Qualifications:
The role will provide technical support for critical large projects. Strong familiarity with the following method platforms is highly preferred: Chromatography, Bioassay, Device, PCR, Microbiology, Immunoassay, CE/Gel, Viral, and General. Protocol and report authoring according to regulatory and industry guidelines (i.e., ICH) and data analysis will be a core activity in this role. This individual may support clinical and commercial locations throughout the company under the guidance of project leads.
Basic Qualifications:
- Pharma or Biotech
- Master’s degree and 2 years of Operations or Scientific experience OR Bachelor’s degree and 4 years of Operations or Scientific experience
- Bachelor's in Biochemistry, Analytical Chemistry, Physical or Life Sciences
- Strong understanding of methods within the following platforms Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel, Device, Viral, and General (compendia)
- Direct experience with method transfer and method validation processes from a Pharmaceutical or Biotechnology Company.
- Knowledge of analytical methods/technologies used in biologic and synthetic development and manufacturing
- Excellent written and oral communication skills for the timely coordination of scientific results in a fast-paced, multi-disciplinary, team-based environment
- Demonstrated ability to manage projects cross functionally
- Demonstrated ability to propose and drive new scientific initiatives