Analytical Development Scientist

Ardena • Franklin Township, NJ

7h • $80,000 - $90,000 • Onsite

About The Position

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. 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.

Requirements

• 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.

Responsibilities

• Provide analytical support for the Analytical Development team in the evaluation, development and validation of analytical methods, with limited supervision.
• 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.
• Assist in complex experiments and tasks 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 development process and provide long term planning for analytical method development and improvement.
• Support formulation development and transfer activities for assigned projects.
• Support the investigations of method performance, reliability and conduct optimizations studies, as needed.
• Participate in the preparation of technical documents, including validation protocols and reports, stability protocols and reports and analytical test procedures.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level