Analytical Development Scientist

About the role

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. The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. European sites are located in Oss and Assen (Netherlands), Ghent (Belgium), and Pamplona (Spain); the U.S. facility is in Somerset, New Jersey. For the Ardena Business Unit based in Somerset (US), we are looking for an Analytical Development Scientist. The scientist will contribute to pharmaceutical development projects by performing scientific, technical, or operational activities within the department, working in a regulated pharmaceutical environment (GMP, GxP, ISO) and collaborating with cross‑functional teams across Ardena’s European and U.S. sites.

Responsibilities

• Hands‑on method development, improvement, and validation, including but not limited to HPLC, GC, dissolution, UV‑Vis spectroscopy, FTIR, KF, microscopy, PSD, etc.
• Assist in complex experiments such as unknown impurity identification and excipient compatibility studies.
• Prioritize activities to provide timely analytical support to product development.
• Anticipate analytical issues early in the R&D process and provide long‑term planning for method development and improvement.
• Support formulation development and transfer activities for assigned projects.
• Investigate method performance, reliability, and conduct optimization studies as needed.
• Participate in the preparation of technical documents, including validation protocols and reports, stability protocols and reports, and analytical test procedures.

Requirements

• Bachelor’s (BS) or Master’s (MS) in Chemistry, Biochemistry, or a related discipline.
• 6–8 years of pharmaceutical industry experience with a BS (or 4+ years with an MS).

Skills

• Working knowledge of GXP, regulatory (ICH) and compendial (USP/EP/JP) requirements during generic development.
• Ability to multi‑task and demonstrate diplomatic skills.
• Excellent verbal and written communication skills in English.
• Strong organizational abilities.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to work effectively under pressure to meet deadlines.

Physical Requirements & Work Environment

• May be required to sit, stand, and walk regularly; occasionally lift 0‑15 pounds.
• Access to manufacturing floor and office staff; use of required office equipment.
• Vision requirements include reading written documents and frequent use of a computer monitor.
• Primary workstation is in an office and laboratory area with low noise level.

Benefits

• Competitive salary and tailored benefits package (adjusted per role and location).
• Flexible working arrangements and paid annual leave (where applicable).
• International and collaborative work environment across European and U.S. sites.
• Access to professional development and training programs.
• Meaningful work on pharmaceutical development projects that advance patient health.
• Values‑driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, Excellent.

Pay

Salary range: $80,000 – $90,000 DOE.