Scientist II, Analytical Development

BioSpace; Boca Raton (FL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental

Tuition Assistance

Paid Time Off

Pet Insurance

Job summary

ADMA Biologics is hiring a Scientist II for Analytical Development in Boca Raton, Florida. The ideal candidate will develop and validate analytical methods, ensure compliance with FDA guidelines, and perform thorough data analysis.

The role requires a Master's degree in a scientific field and at least five years of relevant experience. Benefits include a comprehensive insurance package, 401K with employer match, and educational assistance.

Qualifications

• Master's degree in Chemistry, Analytical Chemistry, Biochemistry, or related field.
• Minimum 5 years of related experience, or 3 years with PhD.
• Expert knowledge of scientific principles and FDA compliance.

Responsibilities

• Develop and validate analytical methods with minimal supervision.
• Write technical reports and present findings to management.
• Analyze data and uphold FDA documentation guidelines.
• Propose efficiencies and improvements to current QC processes.

Skills

Analytical techniques

Data analysis

Regulatory guidelines

Technical reporting

Problem-solving

Education

Master's degree in a scientific discipline

Tools

HPLC

Gas chromatography

Spectroscopy

ELISA

Statistical tools

Job description

Job Description

Scientist II, Analytical Development in Boca Raton, Florida!

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 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-doctoral experience) 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

• 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.