Analytical Development Scientist — CDMO, Flexible Work

Ardena; Franklin Township (NJ); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Competitive salary package

Flexible working arrangements

International environment across US/EU

Job summary

Ardena US Somerset (NJ) is seeking an Analytical Development Scientist to support the analytical development team with method development, validation, and routine QC analyses of APIs and finished products. You will work with HPLC, GC, UV-Vis, FTIR and related instrumentation in a GMP setting.

The role involves collaboration with QA, Regulatory, and Production teams across Ardena’s sites, ensuring compliance with GMP/GxP, and contributing to development projects from discovery to marketed

Qualifications

• BS, MS in Chemistry, Biochemistry or related discipline with 6–8 years (BS) or 4+ years (MS) of experience in the pharmaceutical industry.
• Knowledge of GMP/GxP and regulatory (ICH, USP) requirements in generic development.
• Proficient English communication (verbal and written).
• Strong organization and ability to multi-task in a regulated environment.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to work under pressure to meet deadlines.

Responsibilities

• Provide analytical support for the Analytical Development team, including method development and validation.
• Perform routine analysis of APIs and finished product using HPLC, GC, UV-Vis, FTIR and other instrumentation.
• Assist in unknown impurity identification and excipient compatibility studies.
• Support formulation development and transfer activities for projects.
• Prepare validation protocols and reports, stability reports, and analytical test procedures.

Skills

GXP knowledge

Regulatory knowledge

English communication

MS Office

Organizational skills

Multi-tasking

Laboratory teamwork

Education

BS in Chemistry/Biochemistry

MS in Chemistry/Biochemistry

Tools

HPLC

GC

UV-Vis

FTIR

Job description

Ardena US Somerset (NJ) is seeking an Analytical Development Scientist to support the analytical development team with method development, validation, and routine QC analyses of APIs and finished products. You will work with HPLC, GC, UV-Vis, FTIR and related instrumentation in a GMP setting.

The role involves collaboration with QA, Regulatory, and Production teams across Ardena’s sites, ensuring compliance with GMP/GxP, and contributing to development projects from discovery to marketed