Scientist II, Analytical Development

Initial Therapeutics, Inc.; Boca Raton (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental

Pet Insurance

STD and LTD

Holidays and PTO

Tuition Assistance

Shuttle to Tri-Rail

Job summary

ADMA Biologics in Boca Raton, FL seeks a Scientist II, Analytical Development to advance analytical methods for drug products. The role involves developing, qualifying, and validating assays, writing SOPs, and ensuring adherence to FDA and cGMP guidelines in a collaborative setting.

The position requires a Master’s degree with 5+ years of related experience (PhD with 3 years acceptable). Strong data analysis, SOP writing, and instrumental skills are essential for success.

Qualifications

• Master's degree required in a scientific discipline.
• Five years of related experience with a Master's degree; PhD requires three years.
• Expert knowledge of scientific principles and FDA compliance.
• Experience with cGMP documentation and record-keeping.

Responsibilities

• Develop, qualify, validate analytical and bioanalytical methods and write SOPs.
• Familiar with regulatory guidelines and support submissions.
• Design experiments for qualification and development.
• Perform assays or supervise analysts for qualification/validation.
• Write technical reports and present findings internally or to clients.
• Analyze data with appropriate statistical tools and interpret results.
• Review/approve cGMP documentation when needed.
• Use HPLC, GC, ion chromatography, spectroscopy, ELISA, and potentiometry.
• Propose improvements and support automation efforts.

Skills

Analytical development

Data analysis

SOP writing

cGMP knowledge

Analytical instrumentation

Regulatory understanding

Education

Master's degree in Chemistry/Analytical Chemistry/Biochemistry

PhD in related field (optional)

Tools

HPLC

Gas chromatography

Ion chromatography

Spectroscopy

ELISA

Potentiometry

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.