Job description
Join NovaChem Diagnostics, a fast-growing biotech company dedicated to advancing analytical chemistry for pharmaceutical and biotech clients. We are seeking a Senior Analytical Chemist to lead method development, validation, and quality control initiatives in a regulated environment.
In this role you will work closely with cross-functional teams to design, optimize, and implement robust analytical strategies that ensure product quality and regulatory compliance. You will mentor junior scientists, oversee laboratory operations, and contribute to the scientific direction of our method development programs.
Key technologies include HPLC, LC-MS, GC, and NMR, with emphasis on quantitative analysis, method transfer, and validation under GLP/GMP guidelines.
Responsibility
- Lead development, validation, and transfer of analytical methods (HPLC, LC-MS, GC, NMR) for release, stability, and %R2D assessment in a regulated environment.
- Design and execute experiments to support process development, scale-up, and product characterization.
- Ensure compliance with GLP/GMP, write and maintain SOPs, and prepare documentation for audits and regulatory submissions.
- Analyze data, generate technical reports, and present findings to QA, manufacturing, and research teams.
- Oversee instrument maintenance, calibration programs, and quality control testing to ensure data integrity.
- Mentor and train junior scientists, manage sample tracking, and support lab safety and compliance initiatives.
- Collaborate with CROs and external partners for method validation and technology transfer.
Qualification
- MS or PhD in Chemistry, Analytical Chemistry, or a related field.
- 5+ years of hands-on experience in analytical chemistry, with proficiency in HPLC/LC-MS, GC, and NMR.
- Strong background in method development, validation, transfer, and regulatory compliance (GLP/GMP).
- Proficiency with data analysis and instrument software (e.g., Empower, ChemStation, MassLynx).
- Excellent problem-solving, documentation, and scientific communication skills.
- Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
- Detail-oriented with a strong commitment to quality and data integrity.
- Willingness to support occasional after-hours work and on-call instrument readiness.