Analytical Development Scientist

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

For the Ardena Business Unit based in Somerset (US), we are looking for a Analytical Development Scientist.

Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.

As an Analytical Development Scientist at Ardena, you will contribute to pharmaceutical development projects by performing scientific, technical, or operational activities within the [Department]. You will work in a regulated pharmaceutical environment, ensuring that all work meets GMP, GxP, and applicable ISO standards.

You will collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, Project Management, Production, and other departments across Ardena’s European and US sites.

The primary responsibilities of this position are to provide analytical support for the Analytical Development team in the evaluation, development and validation of analytical methods, with limited supervision. The Scientist will also perform routine analysis of APIs and finished product using laboratory techniques and instrumentation.

• Hands-on method development, method improvement, and validation, including but not limited to HPLC, GC, Dissolution, UV-Vis Spectroscopy, FTIR, KF, Microscopy, PSD etc.
• Assists in complex experiments and tasks such as unknown impurity identification and excipient compatibility studies.
• Prioritizes activities to provide timely analytical support to product development.
• Anticipates analytical issues early in the R&D development process and provides long term planning for analytical method development and improvement.
• Supports formulation development and transfer activities for assigned projects.
• Supports the investigations of method performance, reliability and conducts optimizations studies, as needed.
• Participates in the preparation of technical documents, including validation protocols and reports, stability protocols and reports and analytical test procedures

• BS, MS in Chemistry, Biochemistry or related discipline with 6 – 8 years (BS), 4+ years (MS) of experience in the pharmaceutical industry.

• Working knowledge of GXP, regulatory (ICH) and compendial (USP/EP/JP) requirements during generic development.
• An Ability to multi-task and demonstrate diplomatic skills.
• Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization.
• Strong organizational skills.
• Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to work effectively under pressure to meet deadlines.

• Individual may be required to sit, stand, walk regularly
• Occasionally lift 0-15 pounds
• Be accessible to manufacturing floor and office staff and to use required office equipment
• Specific vision requirements include reading of written documents and frequent use of computer monitor

Individual’s primary workstation is in an office and laboratory area, where the noise level is low.

Ardena is a science-driven and people-focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide.

Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and…