Scientist I, Analytical Development

About the role

The Scientist I, Analytical Development at ADMA Biologics is a key member of the Analytical Development group. They provide analytical support for the Process Development group and manufacturing. The role involves the 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.

Responsibilities

• Development, optimization, validation/qualification, and tech transfer of analytical test methods and bioanalytical 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.
• Performs instrument calibration or qualification according to written procedures.
• Serves 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.
• Reviews and/or approves 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.
• Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management.
• Maintains current knowledge in field of expertise and develops subject matter expertise with analytical technology.

Requirements

• A minimum of 4 years of related lab experience with a Bachelor's degree is required.
• A minimum of 2 years of related lab experience with a Master's degree 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.

Qualifications

• 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.

Skills

• Technical proficiency
• Scientific creativity
• Collaboration with others
• Independent thought

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)

Pay

Competitive compensation.

Schedule

Full time.