PRIMARY DUTIES AND RESPONSIBILITIES:- Perform routine and non-routine chemical analysis of raw materials, in-process samples, and finished products using validated analytical methods.
- Operate and maintain laboratory instrumentation such as HPLC, GC, UV-Vis, FTIR, and other analytical equipment.
- Review and interpret analytical data to ensure compliance with specifications and regulatory requirements.
- Troubleshoot analytical methods, instrumentation issues, and laboratory processes.
- Develop, validate, and transfer analytical methods in accordance with industry standards (e.g., USP, ICH, FDA guidelines).
- Prepare and review laboratory documentation, including test methods, protocols, reports, and SOPs.
- Ensure all laboratory activities comply with cGMP, safety, and company policies.
- Train and mentor junior chemists and laboratory technicians.
- Support internal and external audits and inspections.
- Maintain accurate and timely documentation in laboratory systems (e.g., LIMS, notebooks).
- Collaborate with cross-functional teams, including Quality Assurance, Production, and R&D.
- Assist with investigations related to out-of-specification (OOS) and out-of-trend (OOT) results.
QUALIFICATIONS: - Bachelor's degree in chemistry or related scientific field required; Master's degree preferred.
- Minimum of 5+ years of experience in a pharmaceutical or GMP-regulated laboratory.
- Strong knowledge of analytical techniques such as HPLC, GC, and spectroscopy.
- Familiarity with cGMP, FDA, USP, and ICH guidelines.
- Strong analytical, problem-solving, and organizational skills.
- Ability to work independently and manage multiple priorities.
- Excellent written and verbal communication skills.
We offer medical, dental, vision and company matching 401K.
