Scientist
Job Posting for Scientist at Aditi Consulting
Summary:
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.
Day to Day Responsibilities:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
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.
Day to Day Responsibilities:
- Data verification of analytical method validation and transfer documents
- Data analysis including statistical analysis
- Drafting of analytical method validation and transfer plans, protocols, data appendices, and reports
- 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
- Analytical method validation and transfer experience
- Familiarity with analytical method technologies
- Self-starter with good communication skills
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
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