About This Role
This role is for a GMP Laboratory based Analyst who will perform complex sample preparation and analysis procedures. The work involves quantitatively measuring pharmaceutical, biopharmaceutical, and nutraceutical compounds in various formulations and biological matrices. This position supports the development of dosage forms from clinical studies up to commercialization, utilizing state-of-the-art analytical technologies while maintaining Good Manufacturing Practices (GMP).
Responsibilities
- Perform analytical characterization and assessment of pharmaceutical products, including cGMP compliant stability and release testing for both drug substances and drug products
- Understand and adhere to corporate standards regarding code of conduct, safety, and cGMP compliance
- Comply with all applicable client policies and procedures
- Document and technically review experimental data
- Effectively present results in both oral and written reports
- Maintain laboratory equipment and optimize laboratory operations for safe and efficient use of time and resources
- Troubleshoot equipment and experimental problems
- Review and approve data of other scientists
- Ensure all laboratory records adhere to cGMP/GDP expectations
- Assist in continuous improvement activities
- Be willing to learn new analytical techniques as opportunities arise
Requirements
- 4 years of coursework in a scientific discipline (Chemistry, Biology, Physics, Environmental Science or comparable)
- Experience in specialty techniques (Dissolution, Disintegration, HPLC, UV-vis)
- Experience in analytical methodology, such as chromatography (HPLC/GC), KF, UV-vis and common compendial methods
- Experience with basic bench chemistry skills such as weighing, pipetting
- Familiarity with GMP requirements
- Experience with Microsoft Office (Excel, PowerPoint, and Word)
- Proven ability to interpret data by performing trend analysis
- Proven ability in technical writing skills
- Ability to independently optimize analytical methods
- Proven problem solving and troubleshooting abilities
- Strong written and oral communication skills as well as organizational skills
- Strong attention to detail
- Time management and project management skills
- Ability to work in a collaborative work environment with a team
Nice to have:
- Experience with early and/or late phase method qualification/validation studies
- Experienced in laboratory systems (LIMS, CDS, ELN)
Benefits