Scientist I, Analytical Development

Position Summary

The Scientist I, Analytical Development demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. As a key member of the Analytical Development group provide analytical support for process development group and manufacturing. Be responsible for the development, implementation and execution of routine analytical techniques for protein quantification and characterization.

Essential Functions (ES) and Responsibilities

• Development, optimization, validation/qualification, and tech transfer of analytical test methods and bioanalytical assays such as ELISA, spectrophotometric, chromatographic, gel-based, enzymatic activity and chromogenic assays.
• Design, development, and hands-on execution of analytical studies to support protein characterization and quantitation.
• Perform experiments as needed to generate data for validations and other special projects.
• Evaluate and interpret test and experimental data generated from development/qualification and validation work using Excel or other software as required.
• Collaborate cross-functionality with other departments to select, qualify, and implement reference standards.
• Execute assigned tasks within the constraints of timelines, under minimal supervision by senior scientific staff.
• Troubleshoots technical procedures, methodology and instrumentation.
• Perform instrument calibration or qualification according to written procedures.
• Serve as primary authors, reviewers, and approvers of regulated documents such as method validation/qualification reports, protocols, transfers, SOPs, change controls, investigational reports, and deviations.
• Experience in writing technical reports and presenting findings to internal or external clients.
• Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary.
• Accountable for following Standard Operating Procedures (SOPs), adhering to cGMP guidelines and all relevant compliance regulations.
• Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management.
• Maintain current knowledge in field of expertise and develop subject matter expertise with analytical technology.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education:

• Bachelor of Science (BS) in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is required.
• Master of Science (MS) in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is preferred.
PhD in Biological Sciences, Chemistry, Biochemistry or a relevant discipline is preferred.

Experience:

• A minimum of 4 years of related lab experience with a BS is required.
• A minimum of 2 years of related lab experience with a MS is required.
• Experience in Chemical/Biochemical testing is required.
• Experience in a regulated environment (FDA, EPA, etc.) is required.
• Knowledge of FDA and cGMP requirements are required.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.