Senior Analytical Method Lead – QC & Validation

Anika; Bedford (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Discretionary bonus

Comprehensive healthcare

401(k) with company match

Stock purchase plan

Paid time off

Job summary

Anika Therapeutics in the United States is seeking a Senior Quality Control Analyst to lead method development, validation, optimization, and transfer for new materials and finished products in a cGMP environment. You will perform analytical testing and help ensure regulatory compliance while collaborating with QC, R&D, and Technical Transfer teams.

You will prepare documentation for submissions, support product development, and drive improvements in testing reliability and efficiency across

Qualifications

• Bachelor’s degree in Chemistry or equivalent with 7+ years of relevant experience.
• Minimum five years of laboratory experience developing, validating, and performing analytical methods.
• Five+ years of testing experience in an FDA-regulated pharmaceutical or medical device environment.
• Strong knowledge of GMP and ISO standards and analytical method validation requirements.
• Proficiency with HPLC, GC, FTIR, and UV/Vis analysis.

Responsibilities

• Coordinate with Technical Transfer during product scale-up to ensure analytical testing methods are successfully transferred and implemented in accordance with ICH Q2 guidelines and other applicable method validation requirements.
• Develop, validate, qualify, optimize, and transfer analytical methods for new raw materials, intermediates, finished products, and method improvements.
• Collaborate with R&D to develop analytical test methods for new products and support product development activities.
• Prepare technical reports supporting regulatory submissions, including method development and validation reports, analytical testing results, and product stability data.
• Perform analytical chemistry testing using HPLC, GC, headspace analysis, moisture analyzers, Karl Fischer titration, UV/Vis and FTIR spectrophotometry, and osmometric equipment.
• Conduct testing of in-process, stability, Engineering, and R&D samples using established analytical and physicochemical methods.
• Ensure accurate and timely laboratory documentation in accordance with GDP, review laboratory notebooks, and verify results generated by other analysts.
• Research and optimize analytical methods using accepted industry practices to improve testing reliability, efficiency, and consistency.
• Identify and report procedural deviations and nonconformances, conduct assigned investigations, and support corrective actions through closure.
• Maintain current training and demonstrate proficiency in assigned procedures through documented training, skills development, and classroom instruction as applicable.
• Perform routine maintenance of general laboratory equipment to support reliable laboratory operations.
• Participate in cross-functional projects and initiatives that support business growth, operational effectiveness, and continuous improvement while maintaining cost discipline.

Skills

Analytical method development

Validation and transfer

Regulatory compliance

Lab leadership

Troubleshooting

Education

Bachelor’s degree in Chemistry

7+ years relevant experience

Tools

HPLC

GC

FTIR

UV/Vis

Job description

Anika Therapeutics in the United States is seeking a Senior Quality Control Analyst to lead method development, validation, optimization, and transfer for new materials and finished products in a cGMP environment. You will perform analytical testing and help ensure regulatory compliance while collaborating with QC, R&D, and Technical Transfer teams.

You will prepare documentation for submissions, support product development, and drive improvements in testing reliability and efficiency across