Sr. Scientist I (ARD

You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

This role is a hands-on laboratory position focused on performing analytical testing of raw materials, intermediate materials, and drug substances supporting late-stage clinical and commercial pharmaceutical programs. Approximately 80% of the role is dedicated to laboratory bench work, with a strong emphasis on generating high-quality, accurate, and compliant analytical data.

Primary responsibilities include release testing, in-process and homogeneity testing, stability testing, and reference standard qualification activities using a variety of analytical techniques. The role is heavily focused on HPLC/UPLC analysis, with additional opportunities to utilize GC, Karl Fischer (KF), ion chromatography (IC), and other analytical methods.

The successful candidate will also support method transfers, validation activities, troubleshooting, and continuous improvement initiatives aimed at optimizing analytical methods and supporting method lifecycle management.

Candidates should possess strong attention to detail, adaptability in a dynamic laboratory environment, and a collaborative, team-oriented mindset.

Experience with chromatography systems and data management software such as Empower is highly desirable. Team members typically develop expertise in liquid chromatography techniques first, with opportunities to expand into GC, KF, and other analytical platforms based on project and business needs.

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
• Independently develop and evaluate methodologies, design and implement experiments.
• Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.
• Maintains compliant records with little or no supervision
• Able to write technical documents with assistance
• Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks
• Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions
• Sets up various instrumentation for testing according to written test methods and with little to no supervision.
• As needed, troubleshoots laboratory instrumentation
• Leads a sample project with assistance
• May participate in client level meetings, with approval
• May lead and develop other team members.
• May advise clients on site procedures.
• Responsible for ensuring compliance with cGMP and other regulatory guidelines.
• Analyze information for technical correctness and accuracy
• Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor
• Perform routine laboratory procedures in a timely and efficient manner
• Gain familiarization with analytical techniques
• Participate cGMP activities
• Provides input on SOPs and client questions
• Maintain laboratory equipment and supplies as directed
• May support peer-led laboratory investigations process with assistance
• Maintain a clean and safe work-space
• Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices
• Participate in group and project meetings as required
• Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems
• Attend seminars as required
• Participate in and comply with all current safety, health…