Biologics Analytical Development Scientist - On-site

AL Solutions; Philadelphia (Philadelphia County); On-site; USD 80,000 - 110,000; Full time

Job summary

AL Solutions is seeking an Analytical Development Scientist for a 3-month on-site contract in Philadelphia, PA, supporting biologics development, method qualification and transfer, GMP testing, stability programs and analytical documentation.

You will perform separation-based analytics (HPLC/UPLC, CE-SDS), develop and qualify methods, transfer methods to QC/GMP labs, review chromatograms and data, and ensure GMP data integrity while collaborating with QA, Manufacturing and project teams.

Qualifications

• Experience in Analytical Development or QC within a GMP pharmaceutical or biotechnology environment.
• Hands-on HPLC or UPLC experience.
• Experience developing, qualifying, validating or transferring analytical methods.
• Strong understanding of method parameters including specificity, accuracy, precision, linearity, range and robustness.
• Experience supporting release, stability or development testing.
• Strong GMP documentation and data-review skills.

Responsibilities

• Perform and troubleshoot separation-based analytical testing, including HPLC/UPLC and CE-SDS.
• Support analytical method development, optimisation and qualification.
• Assist with method transfers into QC and GMP laboratories.
• Support development-batch release, stability and characterization testing.
• Review chromatograms, laboratory notebooks and analytical data.
• Author and review methods, protocols, SOPs and technical reports.
• Investigate unexpected results and system-suitability failures.
• Ensure laboratory work meets GMP, GDP and data-integrity requirements.
• Work closely with Analytical Development, QC, Manufacturing and project teams.

Skills

HPLC/UPLC

GMP documentation

Analytical method development

Data review

Troubleshooting

Tools

Empower

LIMS

Job description

AL Solutions is seeking an Analytical Development Scientist for a 3-month on-site contract in Philadelphia, PA, supporting biologics development, method qualification and transfer, GMP testing, stability programs and analytical documentation.

You will perform separation-based analytics (HPLC/UPLC, CE-SDS), develop and qualify methods, transfer methods to QC/GMP labs, review chromatograms and data, and ensure GMP data integrity while collaborating with QA, Manufacturing and project teams.