Senior Analytical Development Chemist
What You'll Do
The Senior Analytical Development Chemist leads the development, validation, transfer, and continuous improvement of analytical methods for raw materials, intermediates, and finished products, ensuring compliance with cGMP regulations and regulatory standards. In this role, you serve as a subject matter expert in analytical method development, analytical instrumentation, and laboratory compliance practices.
How You'll Contribute
• Design, develop, optimize, and troubleshoot analytical methods for raw materials, intermediates, and finished products using chromatographic and spectroscopic techniques.
• Perform analytical method validation activities in accordance with regulatory requirements including ICH, USP, FDA, and internal quality standards.
• Prepare, execute, and summarize validation protocols, reports, technical documentation, and analytical procedures.
• Evaluate analytical method performance characteristics including specificity, linearity, accuracy, precision, robustness, and reproducibility.
• Operate, maintain, and troubleshoot analytical instrumentation including HPLC, GC, LC-MS, ICP-MS, UV-Vis, and FTIR systems.
• Coordinate instrument maintenance, calibration, and vendor support activities to ensure laboratory readiness and compliance.
• Analyze samples supporting stability studies, release testing, in-process controls, and development activities.
• Interpret analytical data and communicate results with scientific accuracy, attention to detail, and data integrity.
• Maintain laboratory records, technical documentation, and analytical data in compliance with cGMP and internal quality system requirements.
• Author and review SOPs, protocols, specifications, technical reports, and other controlled documentation.
• Collaborate cross-functionally with Research & Development, Formulation, Process Development, Manufacturing, and Quality Assurance teams to support product development and commercialization activities.
• Support analytical method transfer activities to Quality Control or manufacturing laboratories.
• Participate in laboratory investigations, audits, CAPAs, and continuous improvement initiatives.
• Evaluate and implement new technologies, digital tools, automation strategies, and process improvements to enhance laboratory capabilities and productivity.
• Mentor junior laboratory staff and provide technical guidance as needed.
• Contribute to additional projects and departmental initiatives as assigned.
What It Takes
This role requires the ability to independently manage analytical development activities of medium to high complexity within a regulated environment. The position exercises judgment in applying scientific principles, troubleshooting analytical challenges, and selecting appropriate methodologies to support product development and quality objectives. Success in this role requires strong technical expertise, analytical problem-solving skills, effective prioritization, and the ability to manage multiple projects and timelines in a collaborative, fast-paced environment.
What You Bring
• MS or PhD in Chemistry, Biology, Pharmaceutical Sciences, or related scientific discipline; equivalent combination of education and experience may be considered.
• Minimum of 5 years of experience in analytical method development and validation within pharmaceutical, biotechnology, medical device, or regulated laboratory environments.
• Expertise with analytical instrumentation and techniques including HPLC, GC, UV-Vis, FTIR, and related analytical technologies.
• Strong understanding of cGMP regulations, regulatory expectations, and laboratory quality systems.
• Experience performing analytical method validation in accordance with ICH, USP, FDA, or related regulatory guidelines.
• Excellent technical writing, documentation, data analysis, and communication skills.
• Strong organizational and time management skills with the ability to manage multiple priorities and deliverables.
• Ability to work independently and collaboratively in a team-oriented environment.
• Flexibility to support work activities and timelines as business needs require.
Nice to Have
• Experience with advanced analytical instrumentation such as LC-MS, ICP-MS, or related technologies.
• Experience supporting analytical method transfer to manufacturing or Quality Control laboratories.
• Experience participating in laboratory audits, investigations, CAPAs, and continuous improvement initiatives.
• Familiarity with lean laboratory practices, automation tools, or digital laboratory systems.
• Experience working in a results-driven, cross-functional team environment.
• Demonstrated commitment to continuous improvement, operational excellence, and exceeding performance 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.