Senior Analytical Development Chemist

Summary of Responsibilities:

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.

Strategic Focus Areas:

Effectively collaborates with internal colleagues and external service providers to meet corporate objectives and drive business results. Demonstrates business and Quality Control knowledge.

Specific Responsibilities:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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

Job Complexity:

The position works on problems of medium to complex scope. The position exercises judgment within defined practices and procedures to determine appropriate action. The position must be able to manage multiple priorities and projects.

Supervisory Responsibilities:

None

Required Qualifications:

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

Desired Experience, Knowledge, and Skills:

• Experience in a result driven, team environment 

• Constantly strives to exceed goals, requirements, accomplishments and expectations

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. 

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

Salary : $90,000 - $120,000