Associate Scientist; ARD

Overview

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

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

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

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. Start a career where You Matter by applying today!

Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss data and methods. Trains and mentors other employees. Additionally, this role may research and implement new methods and technologies to enhance operations.

Efficiently plans and conducts experiments with an increased degree of independence. Prepares research summaries and reports. Experienced with a wide variety of analyses and techniques. Understand principles of and uses safe laboratory work practices. Interacts with clients and participates in FDA and/or client audits.

Maintains professional knowledge through familiarity with scientific literature. Works on problems of diverse scope. Ability to independently plan and schedule experiments. Interprets results from experiments and plans follow up experiments to achieve project objectives. Ability to organize the routine work with minimum supervision. Properly evaluate and interpret generated data. Ability to troubleshoot.

Demonstrates strong understanding of compliance, provides input in site policy regarding compliance questions, ensures that client requests are within the boundaries of compliance.

• 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
• Routinely participates in compliance meetings to ensure that client requests are within boundaries of compliance

• Proficient with a broad range of laboratory techniques and actively investigate new technologies
• Attend and may participate in national and international scientific meetings
• Independently plan, perform and analyze experimental results in a timely manner
• Draft and execute validation protocols for analytical methods
• Perform and review data analysis and draft reports for analytical method development and validation
• Demonstrate ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up and supervision
• Identifies and troubleshoots analytical problems with instrumentation, general chemistry, test methodology and samples submitted

• 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
• May act as a team /project lead supporting scheduling of project tasks and deliverables
• 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…