Senior Analytical Development Chemist

Role Summary

The Senior Analytical Chemist leads the development, validation, and transfer of analytical methods for Anika products. This role involves complex problem-solving, mentoring junior staff, and ensuring compliance with regulatory standards.

Responsibilities

• Method Development
• Design and develop robust analytical methods for raw materials, intermediates, and finished products.
• Optimize chromatographic and spectroscopic techniques (e.g., HPLC, GC, UV-Vis, FTIR).
• Evaluate method parameters such as specificity, linearity, accuracy, precision, and robustness.
• Method Validation
• Perform method validation in accordance with regulatory guidelines (e.g., ICH Q2(R1), USP, FDA).
• Prepare and execute validation protocols and reports.
• Conduct statistical analysis of validation data to ensure method reliability.
• Instrument Operation and Maintenance
• Operate and maintain analytical instruments (e.g., HPLC, GC, LC-MS, ICP-MS).
• Troubleshoot instrument issues and coordinate with vendors for repairs or calibration.
• Documentation and Compliance
• Maintain accurate and complete laboratory records in compliance with GMP standards.
• Write and review SOPs, protocols, and technical reports.
• Ensure compliance with internal quality systems and external regulatory requirements.
• Sample Analysis
• Analyze samples for stability studies, release testing, and in-process controls.
• Interpret and report analytical data with attention to detail and scientific integrity.
• Cross-functional Collaboration
• Work closely with formulation, process development, research and development, and quality assurance teams.
• Support technology transfer of analytical methods to manufacturing or QC labs.
• Continuous Improvement
• Evaluate and implement new technologies or techniques to improve analytical capabilities.
• Support implementation of lean practices, digital tools, or automation to enhance lab productivity
• Participate in laboratory audits and contribute to CAPA (Corrective and Preventive Actions).
• Contribute to other projects as assigned

Qualifications

• Required: MS or PhD in Chemistry, Biology, Pharmaceutical Sciences, or equivalent experience.
• Required: 5+ years of experience in analytical method development and validation.
• Required: Expertise in HPLC, GC, UV-Vis, FTIR, and other analytical techniques.
• Required: Demonstrated experience with cGMP regulations
• Required: Strong understanding of regulatory requirements and quality systems.
• Required: Excellent technical writing, documentation and communication skills.
• Required: Excellent time management skills in meeting with committed deliverables and timeline
• Required: Ability to work flexible hours to complete work activities

• Preferred: Experience in a result driven, team environment
• Preferred: Constantly strives to exceed goals, requirements, accomplishments and expectations

Skills

• Analytical techniques: HPLC, GC, UV-Vis, FTIR, LC-MS, ICP-MS
• Regulatory compliance: cGMP, ICH, USP guidelines
• Technical writing and documentation
• Data analysis and statistical interpretation
• Problem-solving, troubleshooting, and vendor coordination
• Cross-functional collaboration and project management

Education

• MS or PhD in Chemistry, Biology, Pharmaceutical Sciences, or equivalent

Additional Requirements

• None