Scientist II, Analytical Development

ADMA Biologics; Boca Raton (FL); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

401(k) with employer match

Medical, Vision, Life & Dental

Pet Insurance

Paid Holidays

Tuition Assistance

Commute perks

Job summary

ADMA Biologics in Boca Raton, FL is seeking a Scientist II, Analytical Development to advance analytical and bioanalytical methods for biologics. You will design experiments, qualify and validate assays, and guide transfer to QC teams while ensuring compliance with FDA regulations.

The role requires a Master’s degree and 5+ years of related experience, with expertise in HPLC, GC and analytical instrumentation, and strong data analysis skills. On-site position with comprehensive benefits.

Qualifications

• Master's degree in a scientific field is required.
• At least five years of related experience with an advanced degree.
• PhD candidates require three years of experience.

Responsibilities

• Develop, qualify, validate analytical and bioanalytical methods.
• Write SOPs and transfer methods to QC.
• Support regulatory submissions and FDA guidelines.
• Design experiments and write protocols for qualification/development.
• Perform assays or supervise analysts for qualification/validation.
• Prepare technical reports and present findings to management or clients.
• Analyze data with statistical tools and report results.
• Review cGMP documentation and ensure traceability.
• Analyze samples using HPLC, GC, ion chromatography, spectroscopy, ELISA, etc.
• Contribute to method lifecycle improvement and automation.

Skills

Analytical Methods

cGMP

Data analysis

Regulatory docs

Education

Master's degree in Chemistry/Analytical Chemistry/Biochemistry/Biological Sciences/Engineering

Tools

HPLC

Gas chromatography

Ion chromatography

Spectroscopy

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 in Boca Raton, Florida!

Job Title: Scientist II, Analytical Development

Job Description:

Position Summary:

TheScientist II,Analytical Developmentdemonstrates 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 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.

Experience 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-doctoralexperience) is required for a PhD. Expert knowledge of scientific principles and concepts is required.

Compliance Requirements:

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 comprehensivebenefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet InsuranceCompany paid STD and LTD
• Company Paid Holidays3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free 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.