What are the responsibilities and job description for the Analytical Development Scientist II position at ADMA BIOMANUFACTURING LLC?
Job Details
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!
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.
Qualifications
- 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.
- Work collaboratively in cross-functional teams.
- Liaise with customers, staff and suppliers.
- Comply with all safety requirements in all aspects of the work undertaken.
- Use judgment, creativity and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management.
- Interact with contract labs in a method development/qualification/validation if necessary.
- Constantly observe current QC methods and propose areas for improvement.
- Maintain current knowledge in field of expertise through reading articles and attending technical courses.
- 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.
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.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 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)
- Easily accessible to Tri-Rail
- Company paid shuttle to the Boca Tri-Rail station
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.
