Scientist II at Cambrex in Durham, North Carolina

Job Description:

Cambrex


Scientist II

US-NC-Durham

Job ID: 2024-4002
Type: Regular Full-Time
# of Openings: 1
Category: Analytical Services
Cambrex - Durham

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 with supervision
and to evaluate and interpret generated data.

Works on problems of moderate 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.

Responsibilities

• Execute analytical methods for in-process control, release testing and stability
  monitoring of bulk drug substances and drug products under cGMP guidelines
• 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
• 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
• 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 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 (SOPs), methods, qualification
  protocols and other standard documents as directed
• With guidance, prepares well written and organized development reports
• Performs other related duties as assigned.

Qualifications

B.S./B.A. Chemistry with 4+ years of experience in related industry or MS with 0+ years
related experience

PI257078315

Salary:

$66,209.00

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