Analytical Scientist I – In-Process & Release Testing

Cambrex Corp.; Durham (NC); Vor Ort; USD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Healthcare

Life Insurance

Retirement Plan

Zusammenfassung

Cambrex Corp. in the United States is seeking an analytical professional to execute methods and support release/stability testing of drug substances and products under cGMP. You will organize routine work with supervision and evaluate data to ensure quality and regulatory compliance.

Responsibilities include setting up instrumentation, generating and communicating results, maintaining SOPs, and contributing to CAPAs and development reports in a fast-paced team environment.

Qualifikationen

• 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.
• Able to comply to SOPs and basic regulatory compliance
• Working knowledge of scientific concepts, principles and procedures
• Actively and positively engages with team and supports process improvements
• Good understanding of current FDA and cGMP regulations
• General knowledge of chemistry and scientific calculations
• Hands on experience in analytical techniques such as HPLC, GC, etc
• Basic computer skills
• Ability to operate laboratory equipment and computers
• Ability to take direction from experienced scientists and contributes in a team environment
• Good problem-solving skills
• Good attention to details
• Can repeat and follow detailed scientific procedures with supervision
• Able to clearly present results verbally in group meetings and in written progress reports
• Good interpersonal skills and is willing to ask questions about procedures and concepts
• Aptitude and willingness to gain more skills and knowledge in support of GMP regulations
• Good written and verbal communication skills
• Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel.
• Aptitude and willingness to gain more skills & knowledge.
• Good attention to detail and good problem-solving skills.

Aufgaben

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
• Maintain working knowledge 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.
• 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.

Kenntnisse

Analytical method development

cGMP compliance

Data analysis & interpretation

SOP adherence

FDA regulations familiarity

Team collaboration

Effective communication

Detail orientation

Problem solving

Lab equipment operation

Cross-functional teamwork

Ausbildung

B.S./B.A. Chemistry

Tools

Empower

ChemDraw

Microsoft Word

PowerPoint

Excel

HPLC

GC

Jobbeschreibung

Cambrex Corp. in the United States is seeking an analytical professional to execute methods and support release/stability testing of drug substances and products under cGMP. You will organize routine work with supervision and evaluate data to ensure quality and regulatory compliance.

Responsibilities include setting up instrumentation, generating and communicating results, maintaining SOPs, and contributing to CAPAs and development reports in a fast-paced team environment.