Analytical Development Scientist – GMP & Method Innovation
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Benefits offered by this job
Job summary
Ardena, a global CDMO/CRO with a Somerset, NJ base, is seeking an Analytical Development Scientist to drive analytical method development, validation, and trouble-shooting within a GMP environment. You will collaborate with QA, Regulatory, Project Management, and Production across Ardena’s US and European sites to support drug substance and product development.
The role emphasizes hands-on method development, verification, and transfer activities, with a requirement for strong English
Qualifications
- BS or MS in chemistry/biochemistry with pharma industry experience.
- 4+ years (MS) or 6-8 years (BS) in analytical development in pharma.
- GXP/ICH/USP/EP knowledge required.
Responsibilities
- Develop, improve, and validate analytical methods (HPLC, GC, etc.).
- Assist in unknown impurity identification and excipient compatibility studies.
- Prioritize activities to provide timely analytical support to product development.
- Anticipate analytical issues and plan long-term method development and improvement.
- Support formulation development and transfer activities for assigned projects.
- Investigate method performance, reliability, and optimization as needed.
- Prepare validation protocols, reports, stability protocols, and test procedures.
Skills
Education
Tools
Job description
Ardena, a global CDMO/CRO with a Somerset, NJ base, is seeking an Analytical Development Scientist to drive analytical method development, validation, and trouble-shooting within a GMP environment. You will collaborate with QA, Regulatory, Project Management, and Production across Ardena’s US and European sites to support drug substance and product development.
The role emphasizes hands-on method development, verification, and transfer activities, with a requirement for strong English
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