Senior Analytical QC Lead: Method Dev & Validation (Onsite)

Anika Therapeutics, Inc.; Bedford (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Discretionary bonus

Comprehensive healthcare

401(k) with up to 5% company match

Employee stock purchase plan

Paid time off

Job summary

Anika Therapeutics, Inc. in the United States is seeking a Senior Quality Control Analyst to lead method development, validation, and transfer for new materials and finished products in a cGMP environment.

You will collaborate with QA, R&D, and Technical Transfer to ensure analytical methods support scale-up and regulatory submissions. Ideal candidates have extensive experience in analytical chemistry, GMP, HPLC/GC/FTIR/UV-Vis, and proven ability to manage multiple projects while ensuring data

Qualifications

• Bachelor’s degree in Chemistry or another physical science, or 7+ years equivalent experience.
• Minimum of five years developing, validating, and performing analytical methods.
• Five+ years of FDA-regulated pharma or medical device testing experience.
• Demonstrated knowledge of GMP, ISO standards, and analytical method validation requirements.
• Proficiency with HPLC, GC, FTIR, and UV/Vis.
• Strong analytical, problem-solving, and organizational skills, with ability to manage multiple projects and meet deadlines.

Responsibilities

• Coordinate method transfer during product scale-up to ensure testing methods are transferred per ICH Q2 guidelines.
• Develop, validate, qualify, optimize, and transfer analytical methods for new materials, intermediates, and finished products.
• Collaborate with R&D to develop analytical test methods for new products and support development activities.
• Prepare technical reports supporting regulatory submissions, including method development/validation results and stability data.
• Perform analytical testing using HPLC, GC, FTIR, UV/Vis, and related equipment.
• Maintain GDP-compliant documentation and review notebooks; verify results.

Skills

Analytical method development

Method transfer

Regulatory compliance

Problem solving

Documentation

Education

Bachelor’s degree in Chemistry or physical science

Tools

HPLC

GC

FTIR

UV/Vis

Karl Fischer

Moisture analyzers

Osmometry

Job description

Anika Therapeutics, Inc. in the United States is seeking a Senior Quality Control Analyst to lead method development, validation, and transfer for new materials and finished products in a cGMP environment.

You will collaborate with QA, R&D, and Technical Transfer to ensure analytical methods support scale-up and regulatory submissions. Ideal candidates have extensive experience in analytical chemistry, GMP, HPLC/GC/FTIR/UV-Vis, and proven ability to manage multiple projects while ensuring data