Scientist (QC)

Ardena • Franklin Township, NJ

7h • $85,000 - $92,500 • Onsite

About The Position

As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support.
With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.
We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.
If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.
For the Ardena Business Unit based in Somerset (US), we are looking for a QC Scientist.
The Scientist works with others, for the successful and timely testing of new and commercial pharmaceutical products using conventional, current and new analytical technologies to support formulation development and for the quality control of raw materials, intermediates, finished product and stability samples by analyzing data and interpreting results, and communicating findings through reports for the development of new and existing products.

Requirements

• AS Chemistry/Analytical Chemistry with 5+ years of experience in analytical support of pharmaceutical product manufacture and development OR
• BS Chemistry/Analytical Chemistry with 3+ years of experience in analytical support of pharmaceutical product manufacture and development
• Experience and knowledge of scientific principles and concepts and analytical instrumentation.
• Experience in Analytical Quality Control for Pharmaceutical Development.
• Ability to organize and prioritize diverse tasks and projects.
• Proficiency in analytical instrumentation (LC, GC, Dissolution), CDMS and LIMS systems and Microsoft Office including but not limited to Teams, Word, Excel, PowerPoint.
• Ability to interpret a variety of instructions furnished in written, oral, visual, or schedule form
• Ability to work effectively under pressure to meet deadlines
• Mathematical and reasoning ability with verbal and written communication proficiency.
• Individual maybe required to occasionally lift 0-15 pounds and will access GMP laboratory and plant and office areas.
• Required to read and understand written documents and will have frequent use of computer screens.
• Must wear safety glasses, in addition to other specified PPE, in all designated areas.
• Must follow any applicable site safety requirements.
• Must be fit-tested as per OSHA regulations, trained and capable of wearing air purifying respirator.
• Must be trained in plant hazardous material procedures.
• Must use approved fall prevention devices when performing elevated tasks.
• Must be capable of wearing safety shoes for 8 to 12 hours a day, depending on duration of the shift.
• Working conditions will be Temperature and Humidity controlled as needed for product.
• Individual’s primary work-area is located in the Laboratory and office area, where the noise level can be low to moderate.

Responsibilities

• Works on problems of moderate scope where analysis requires in-depth evaluation.
• Performs laboratory testing efficiently with minimal errors (execution and documentation).
• Independently completes assigned projects and activities to meet agreed milestones and deliverables for clinical and commercial manufacture.
• Conducts QC activities required for the timely completion of sample analysis associated with raw material, in-process, finished product and stability test samples.
• Analytical techniques used include but are not limited; Chromatographic analysis, dissolution testing and standard wet chemistry using conventional methods of analysis, instrumentation and electronic systems including where applicable CDMS, LIMS and ELN.
• Interprets, evaluates, communicates, and properly documents the results of work.
• Evaluate data for accuracy, completeness and integrity as a qualified and effective data reviewer
• Conducts and documents laboratory investigations and deviations.
• Prepares reports and presentations, verbal and written on project progress; authors and reviews test methods, reports, protocols, SOPs and specifications.
• Collaborates with other groups as necessary to ensure project requirements are met.
• Performs other miscellaneous technical and administrative duties as required to meet company objectives.
• Is proficient in and supports Quality and Laboratory systems and infrastructure including change management as required.
• Perform duties in accordance with the company mission and values.
• Maintains appropriate standards of cGMP, Health, Safety and Environmental.
• Adheres to company and site standards for data integrity and regulatory compliance.
• Other tasks as required

Benefits

• A competitive salary with a tailor-made benefits package, including: medical, dental and vision benefits effective day one of employment
• Paid Time Off
• A dynamic, global work environment with career growth opportunities
• Access to Ardena Academy, our internal learning platform for professional development
• A chance to contribute to groundbreaking drug development projects that make a real impact

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree