TALENT Pipeline-Sr. Scientist ; ARD

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You Matter to Cambrex. 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.

Job Overview 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. Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors.

Exercises judgment within defined procedures and practices to determine appropriate action.

• 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 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 and environmental programs
• Shows initiative and interest in learning new techniques and tests
• Participates in technical discussions and brainstorming sessions
• Communicates issues or challenges to senior staff and/or management
• May review test data acquired by others and witness others’ notebooks
• Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs
• Assists with writings standard operating procedures, methods, qualification protocols and other standard documents as directed
• With guidance, prepares well written and organized development reports
• Performs 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
• Understands the chemical properties…