Senior Analytical Development Scientist

Ardena; New Jersey; On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Competitive salary package

Flexible working arrangements

Professional development

International environment

Meaningful work in pharma development

Job summary

Ardena, a US-based CDMO/CRO with a Somerset, New Jersey facility, is seeking an Analytical Development Scientist to support development and validation of analytical methods for APIs and finished products. The role emphasizes GMP, GxP, and regulatory compliance in a cross-functional environment.

You will perform hands-on method development (HPLC, GC, dissolution, UV-Vis) and contribute to documentation, validation, and transfer activities, collaborating with QA, Regulatory Affairs, and Production.

Qualifications

• BS with 6–8 years (BS) or MS with 4+ years in the pharmaceutical industry.
• Working knowledge of GXP, regulatory (ICH) and compendial (USP/EP/JP) requirements.
• Excellent English communication, both verbal and written.

Responsibilities

• Develop, improve, and validate analytical methods (HPLC, GC, dissolution, UV-Vis, FTIR, KF).
• Assist in unknown impurity identification and excipient compatibility studies.
• Prioritize activities to deliver timely analytical support to product development.
• Plan long-term analytical method development and improvements.
• Support formulation development and transfer activities.
• Investigate method performance and conduct optimization studies.
• Prepare technical documents, validation protocols and reports.

Skills

English communication

Multi-tasking

Organizational skills

Working under pressure

Education

BS/MS in Chemistry or related field

Tools

HPLC

GC

Dissolution

UV-Vis

FTIR

KF

Microscopy

Job description

Ardena, a US-based CDMO/CRO with a Somerset, New Jersey facility, is seeking an Analytical Development Scientist to support development and validation of analytical methods for APIs and finished products. The role emphasizes GMP, GxP, and regulatory compliance in a cross-functional environment.

You will perform hands-on method development (HPLC, GC, dissolution, UV-Vis) and contribute to documentation, validation, and transfer activities, collaborating with QA, Regulatory Affairs, and Production.