Job Description
Overview:
This role is a hands-on laboratory position focused on performing analytical testing of raw materials, intermediate materials, and drug substances supporting late-stage clinical and commercial pharmaceutical programs. Approximately 80% of the role is dedicated to laboratory bench work, with a strong emphasis on generating high-quality, accurate, and compliant analytical data.
Primary responsibilities include release testing, in-process and homogeneity testing, stability testing, and reference standard qualification activities using a variety of analytical techniques. The role is heavily focused on HPLC/UPLC analysis, with additional opportunities to utilize GC, Karl Fischer (KF), ion chromatography (IC), and other analytical methods.
The successful candidate will also support method transfers, validation activities, troubleshooting, and continuous improvement initiatives aimed at optimizing analytical methods and supporting method lifecycle management.
Candidates should possess strong attention to detail, adaptability in a dynamic laboratory environment, and a collaborative, team-oriented mindset.
Experience with chromatography systems and data management software such as Empower is highly desirable. Team members typically develop expertise in liquid chromatography techniques first, with opportunities to expand into GC, KF, and other analytical platforms based on project and business needs.
Responsibilities:
- 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 (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 - Provides input on SOPs and client questions
- 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 relating to method development, qualification
/validation and troubleshooting. - 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
- Ability to read and execute compendial methodologies
- Strong 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
- Routinely and effectively presenting findings to clients
- 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.
- Bachelor’s degree in Chemistry or a related scientific discipline with a minimum of 6 years of relevant pharmaceutical, biotech, or analytical laboratory experience; or
- Master’s degree in Chemistry or a related scientific discipline with a minimum of 2 years of relevant pharmaceutical, biotech, or analytical laboratory experience.
- This position is designed for candidates with significant hands-on laboratory testing experience in a GMP-regulated environment.
Numbers & Facts
| Location | Durham, North Carolina |
| Job Type | Full-time |
| Industry | Biotechnology/Pharmaceuticals |
| Company Size | 1,000 to 1,499 employees |
| Year Founded | 1981 |
| Website | http://www.cambrex.com |
About Company
Cambrex is an innovative life sciences company with a refreshingly human approach. Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world.
With over 35 years of active pharmaceutical ingredient (API) development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets.
Skills
- Analysis Skillsunmatched
- Biotech and Pharmaceuticalunmatched
- Chemistryunmatched
- Chromatographic Systemsunmatched
- Chromatographyunmatched
- Communication Skillsunmatched
- Computer Skillsunmatched
- Computer Softwareunmatched
- Continuous Improvementunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Data Managementunmatched
- Detail Orientedunmatched
- Develop Methodologiesunmatched
- Drug Productsunmatched
- Environmental Workunmatched
- Equipment Maintenance/Repairunmatched
- Experiment Designunmatched
- FDA Requirementsunmatched
- GMP (Good Manufacturing Practices)unmatched
- High Performance Liquid Chromatography (HPLC)unmatched
- IR (Infrared)unmatched
- Identify Issuesunmatched
- Instrumentationunmatched
- Integrated Circuits (ICs)unmatched
- Laboratoryunmatched
- Laboratory Equipmentunmatched
- Laboratory Information Management System (LIMS)unmatched
- Laboratory Notebookunmatched
- Laboratory Techniquesunmatched
- Laboratory Testingunmatched
- Liquid Chromatographyunmatched
- Maintain Complianceunmatched
- Materials Analysisunmatched
- Materials Testingunmatched
- Microsoft Excelunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Nuclear Magnetic Resonanceunmatched
- Organic Chemistryunmatched
- Organizational Skillsunmatched
- People Managementunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Procedure Developmentunmatched
- Process Control Engineeringunmatched
- Process Improvementunmatched
- Progress Reportsunmatched
- Quality Assurance Methodologyunmatched
- Record Keepingunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Reporting Skillsunmatched
- Safety Complianceunmatched
- Safety/Work Safetyunmatched
- Scientific Principlesunmatched
- Standard Operating Procedures (SOP)unmatched
- Team Playerunmatched
- Technical Supportunmatched
- Technical Writingunmatched
- Test Dataunmatched
- Testingunmatched
- Time Managementunmatched
- Writing Skillsunmatched
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