We are a pharmaceutical analytical laboratory specializing in advanced analytical testing services for compounded preparations, active pharmaceutical ingredients (APIs), sterile preparations, nutraceuticals, and finished pharmaceutical products.
Our laboratory utilizes state-of-the-art instrumentation including LC-MS/MS and ICP-MS to provide high-quality analytical services including potency testing, stability-indicating assays, impurity profiling, elemental impurity testing, and method development/validation.
We are seeking an experienced and highly motivated Senior R&D / QA Analyst to join our analytical laboratory team.
Position Overview
This is not a routine QC analyst position.
The successful candidate will be responsible for independently developing, optimizing, validating, and executing analytical methods for pharmaceutical products and raw materials. The candidate must possess strong technical expertise in chromatography and elemental analysis and be comfortable working with complex pharmaceutical matrices.
Candidates must have a minimum of 2–3 years of direct hands-on experience operating HPLC, LC-MS, and ICP-MS systems in a pharmaceutical, biotechnology or analytical testing environment.
Primary Responsibilities
Method Development & Validation
- Develop and optimize analytical methods for pharmaceutical and nutraceutical products.
- Design and execute stability-indicating methods capable of separating APIs from degradation products.
- Perform method validation studies in accordance with ICH guidelines.
- Prepare validation protocols, validation reports, and technical documentation.
- Support method transfers and analytical troubleshooting activities.
Pharmaceutical Testing
- Conduct potency testing of APIs and finished dosage forms.
- Perform related substances and impurity analysis.
- Conduct stability studies and stability-indicating assays.
- Analyze pharmaceutical samples for degradation products and contaminants.
- Perform elemental impurity testing and heavy metal analysis using ICP-MS.
- Review, interpret, and approve analytical data.
Quality Assurance & Compliance
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
- Prepare and review SOPs, analytical reports, specifications, and laboratory records.
- Maintain compliance with laboratory quality systems and Good Documentation Practices.
- Participate in equipment qualification, calibration review, and preventive maintenance programs.
- Support regulatory inspections, audits, and client technical inquiries.
Instrumentation
Hands-on experience with the following instrumentation is mandatory:
Experience with the following is considered an asset:
- UV-Visible Spectrophotometry
- Dissolution Testing
- FTIR
- Karl Fischer Titration
Mandatory Qualifications
- Master’s Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biotechnology, Biochemistry, or related scientific discipline.
- Minimum 2–3 years of hands-on industry experience operating HPLC, LC-MS, and ICP-MS instrumentation.
- Demonstrated experience developing analytical methods from concept through validation.
- Experience performing:
- Potency assays
- Stability-indicating assays
- Impurity profiling
- Heavy metal and elemental impurity testing
- Strong understanding of chromatographic theory and analytical chemistry principles.
- Ability to independently troubleshoot instruments, methods, and analytical issues.
- Excellent technical writing and documentation skills.
Preferred Qualifications
- Master’s in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, or related field.
- Experience in a GMP, GLP, ISO 17025, pharmaceutical, or contract analytical laboratory environment.
- Familiarity with:
- ICH Q2 (Analytical Method Validation)
- ICH Q3D (Elemental Impurities)
- ICH Stability Guidelines
- USP Analytical Chapters
- Experience with software platforms such as:
- Agilent MassHunter
- OpenLab CDS
- Empower
- ChemStation
Desired Attributes
- Scientific curiosity and problem-solving mindset.
- Strong attention to detail.
- Ability to work independently with minimal supervision.
- Excellent communication and collaboration skills.
- Ability to manage multiple projects and deadlines simultaneously.
- Commitment to data integrity, quality, and regulatory compliance.
Compensation
- Salary: $55,000 – $75,000 annually
- Compensation will be determined based on technical expertise, educational background, and relevant industry experience.
How to Apply
Interested candidates should submit:
- Resume
- Cover Letter
- Summary of experience with HPLC, LC-MS, and ICP-MS instrumentation
- Examples of analytical methods developed or validated (if available)
Please note: Candidates without direct hands-on experience in HPLC, LC-MS, and ICP-MS operation and method development will not be considered.
Pay: $55,000.00-$75,000.00 per year
Benefits:
- Casual dress
- Dental care
- On-site parking
- Paid time off
- Vision care
Work Location: In person
