Analytical Development Scientist

Ardena; Franklin Township (NJ); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Competitive salary package

Flexible working arrangements

International environment across US/EU

Job summary

Ardena US Somerset (NJ) is seeking an Analytical Development Scientist to support the analytical development team with method development, validation, and routine QC analyses of APIs and finished products. You will work with HPLC, GC, UV-Vis, FTIR and related instrumentation in a GMP setting.

The role involves collaboration with QA, Regulatory, and Production teams across Ardena’s sites, ensuring compliance with GMP/GxP, and contributing to development projects from discovery to marketed

Qualifications

• BS, MS in Chemistry, Biochemistry or related discipline with 6–8 years (BS) or 4+ years (MS) of experience in the pharmaceutical industry.
• Knowledge of GMP/GxP and regulatory (ICH, USP) requirements in generic development.
• Proficient English communication (verbal and written).
• Strong organization and ability to multi-task in a regulated environment.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to work under pressure to meet deadlines.

Responsibilities

• Provide analytical support for the Analytical Development team, including method development and validation.
• Perform routine analysis of APIs and finished product using HPLC, GC, UV-Vis, FTIR and other instrumentation.
• Assist in unknown impurity identification and excipient compatibility studies.
• Support formulation development and transfer activities for projects.
• Prepare validation protocols and reports, stability reports, and analytical test procedures.

Skills

GXP knowledge

Regulatory knowledge

English communication

MS Office

Organizational skills

Multi-tasking

Laboratory teamwork

Education

BS in Chemistry/Biochemistry

MS in Chemistry/Biochemistry

Tools

HPLC

GC

UV-Vis

FTIR

Job description

About Ardena

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 aAnalytical 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.

Summary of Essential Functions:

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.

Specific Duties, Activities, and Responsibilities:

• 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

Position Requirements:

Education and Experience:

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

Knowledge/Skills:

• 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.

Physical Requirements:

• 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

Work Environment/Safety Conditions:

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

What Ardena Offers

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 locations.

Benefits and perks at Ardena include:

• 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

Salary Range $80,000 -$90,000 DOE