Reporting To: Director AR&D
Location: Hauppauge, NY
- Utilize scientific expertise to independently develop, verify/validate and transfer analytical methods for drug substance, excipients, dietary substances, and residuals (e.g. assay, related compounds, residual solvents, elemental impurities, etc.) using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, Malvern particle size analysis, etc. Design method transfer, verification and validation protocols and reports compliant with cGMP regulations, industry standards, and customer direction. Properly maintain all developmental samples and standards.
- Prepare SOPs, method of analysis and design development specifications.
- Troubleshoot analytical methods for testing drug substances and excipients to support Quality Control Laboratories.
- Other responsibilities as assigned by Senior Management.
- Master degree in chemistry with 3-5 years of pharmaceutical experience
- Ability to provide technical guidance and troubleshooting on development and validation of analytical methods
- Thorough understanding of cGMP, FDA/ICH/EU regulations and guidelines
- Working knowledge of computer programs: Empower 1-3, Chemstation, EZChromElite,
- Microsoft Word, Works, Excel, Publisher, Outlook.
- Fast learner with ability to apply knowledge
- Able to work independently and manage multiple projects in a fast paced environment
- Play a key role in working with relevant analytical team members to harmonize procedures
CPC is offering a professional, stable work environment with excellent opportunity for career advancement in a dynamic company, a competitive salary and a comprehensive benefits package, which includes medical, dental, life insurance, paid time-off and 401(k) plan with matching contributions.