Scientist II, Analytical Development

About the role

ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. The Scientist II, Analytical Development demonstrates technical proficiency, scientific creativity, collaboration, and independent thought while working on complex problems requiring evaluation of identifiable factors. This role involves exercising judgment within generally defined practices and policies to select methods and techniques for obtaining solutions.

Responsibilities

• Develop, qualify, and validate analytical and bioanalytical test methods and assays with minimal supervision.
• Write SOPs and transfer methods to the QC department as needed.
• Be familiar with regulatory guidelines for assay development, qualification, validation, and support regulatory submissions.
• Design experiments and write protocols for assay qualification and development.
• Perform assays or supervise other analysts for assay qualification and validation work.
• Write technical reports and present findings internally to management or external clients.
• Analyze experimental data using appropriate statistical tools and report scientific results.
• Interpret data and adhere to strict documentation guidelines when recording data.
• Review and/or approve cGMP documentation generated by other analysts in the laboratory as necessary.
• Analyze samples from various sources to provide information on compounds or quantities present.
• Use analytical techniques and instrumentation such as gas and high-performance liquid chromatography (HPLC), ion chromatography, spectroscopy (infrared, ultraviolet), ELISA, and potentiometry.
• Serve as a subject matter expert for a range of analytical techniques, instrumentation, and software.
• Develop new techniques for the analysis of drug products and chemicals.
• Use judgment, creativity, and technical knowledge to recommend solutions to problems as directed by management.
• Observe current QC methods and propose areas for improvement.
• Perform risk and gap assessments and lifecycle management of existing methods/systems to support FDA’s requirement for continuous improvement.
• Propose efficiencies to existing processes and be familiar with laboratory automation.

Requirements

• A minimum of a Master’s degree in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering, or equivalent is required.
• A minimum of five years of related employment experience is required with a Master’s degree. Three years of experience (may include post-doctoral experience) is required for a PhD.
• Expert knowledge of scientific principles and concepts is required.

Compliance

The minimum compliance expectation for this role includes 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. The role also requires proactive participation in compliance reviews, prompt reporting of potential issues, and ongoing education to stay updated on relevant FDA regulations.

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)
• Free shuttle to the Boca Tri-Rail station