Scientist II, Analytical Development

Job Description

ADMA Biologics  is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a  Scientist II, Analytical Development located in Boca Raton, FL!

Job Title :

Scientist II, Analytical Development

Job Description : Position Summary

The  Scientist II, Analytical Development  demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought.  Works on complex problems in which analysis of data requires evaluation of identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Essential Functions (ES) and Responsibilities

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

Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP’s and procedures with great attention to detailAble to work in high-pressure, deadline-driven environmentDemonstrated ability to achieve goals, overcome obstacles, and meet deadlinesPossess time management skills and be able to balance multiple job assignments at oncePossesses excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross-functional teams and communicate findings and recommendationsExperience Requirements

Education 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.

Experience Requirements :

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.

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.

Job Description Footer :

In addition to competitive compensation, we offer a comprehensive benefits package including :

ADMA Biologics  uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit  www.dhs.gov / E-Verify .

ADMA Biologics  is an Equal Opportunity Employer.