Analytical Development Scientist II – Method Validation

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 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.