Scientist II; ARD

Overview

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 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 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 in a safe environment, and strengthen connections with coworkers and the community. We offer a competitive benefits package including healthcare, life insurance, planning for retirement, and more.

Known for customer-focused scientific and manufacturing excellence, strong commitment to quality and safety, we offer career and growth opportunities across our global locations. 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 with supervision and to evaluate and interpret generated data. Works on problems of moderate scope; analyzes data and applies defined procedures.

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
• Participate in experimental design, including development of methods and testing requirements to demonstrate method suitability
• Maintain compliant records with little or no supervision
• Write technical documents with assistance
• Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and methodologies
• Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions
• Set up instrumentation for testing with little to no supervision
• Troubleshoot laboratory instrumentation as needed
• Lead a sample project with assistance
• Participate in client level meetings, with approval
• Ensure compliance with cGMP and other regulatory guidelines
• Analyze information for technical correctness and accuracy
• Compile, maintain, interpret and extrapolate data and communicate results to supervisor
• Perform routine laboratory procedures in a timely and efficient manner
• Gain familiarization with analytical techniques
• Participate in cGMP activities
• Maintain laboratory equipment and supplies as directed
• Support peer-led laboratory investigations with assistance
• Maintain a clean and safe workspace
• Maintain laboratory notebooks and/or computer files (e.g., LIMS) according to practices
• Participate in group and project meetings as required
• Enter project hours promptly and update project status in tracking/timekeeping systems
• Attend seminars as required
• Participate in and comply with safety, health and environmental programs
• Show initiative to learn new techniques and tests
• Participate in technical discussions and brainstorming
• Communicate issues to senior staff and management
• Review test data and witness notebooks as needed
• Assist with writing technical documentation (OOS, investigations, deviations and CAPAs)
• Assist with writing SOPs, methods, qualifications, protocols and other documents
• Prepare well written development reports with guidance
• Perform other related duties as assigned

• Working knowledge of experimental design, including chemistry supporting method development
• Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC
• Working exposure to cross-functional techniques including organic chemistry
• Ability to comply with SOPs and basic regulatory compliance
• Working knowledge of scientific concepts, principles and procedures
• Actively and positively engages with team and supports process improvements
• Ability to read and execute compendial…