Analytical Development Scientist - Biologics

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

Analytical Development Scientist – Biologics

Philadelphia, PA | On-site | 3-Month Contract | 40 hours per week

AL Solutions is exclusively supporting a growing biologics CDMO seeking an experienced Analytical Development Scientist for an initial 3-month contract, with the potential to extend.

This is a hands-on laboratory position supporting biologics development, method qualification and transfer, GMP testing, stability programs and analytical documentation. The successful scientist should be able to join the laboratory quickly and contribute with minimal training.

Key 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

Experience Required:

• 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
• Ability to work onsite in Philadelphia, Pennsylvania

Particularly Valuable Experience:

• Biologics, monoclonal antibodies, proteins, vaccines or advanced therapies
• SEC, IEX/AEX/CEX, RP-HPLC or RP-UPLC
• CE-SDS, cIEF, GC or other separation-based techniques
• Empower, LIMS and electronic laboratory notebooks
• OOS/OOT investigations, CAPAs and laboratory troubleshooting
• Experience working within a CDMO or client-facing laboratory

Why consider this opportunity?

• Immediate opportunity within a growing biologics CDMO
• Hands-on role with exposure to development and GMP programs
• High-impact work supporting commercial manufacturing readiness
• Initial three-month contract with the potential to extend