Associate Scientist, Biologics Analytical Operations

仕事内容

Job Responsibilities:

• Contribute to ATP driven analytical method development, optimization and troubleshooting.

• Demonstrates skills in data analysis (ex: HPLC, CE, Mass Spec) and ability to evaluate quality of data.

• Assists supervisor in critical data review and troubleshooting at external CTLs and CMOs.

• Independently plans and executes assigned experiments that support non-routine development activities and project goals.

• Maintains high level of expertise through familiarity with scientific literature and applies appropriately to development projects.

• Recommends alternatives, researches new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems.

• Participates in cross-functional projects to ensure method development activities are completed timely.

• Author and revise test methods.

Education, Experience & Required Skills:

• MS degree with 3+ years’ experience or BS degree with 5+ years’ relevant industry experience.

• Demonstrates and applies an advanced level of understanding project goals and methods.

• Familiar with DOE tools for method development.

• Proficient with analytical techniques as liquid chromatography, capillary electrophoresis, cIEF, and other commonly used techniques for biologics.

• Understands the analytical life cycle concepts as applied to analytical development.

• Knowledge of current Good Manufacturing Practices.

• Must think critically and creatively, determine appropriate resources for resolution of problems and have strong organizational and planning skills.

• Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.