Senior Analytical Development Chemist
Anika Therapeutics•Bedford, MA
About The Position
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.
Requirements
- 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 Haves
- 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.
Responsibilities
- 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.
Benefits
- discretionary bonus program
- 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
- long-term incentives including stock awards
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What This Job Offers
Job Type
Full-time
Career Level
Senior
