POSITION SUMMARYThe Senior Analytical Chemist will be responsible for developing and qualifying analytical test methods for raw materials, intermediates, and finished products. They will lead complex chemical analyses, develop and validate new methods, and provides technical expertise in a laboratory setting in direct support of manufacturing and R&D. This role requires working closely with internal and external experts, managing the transfer of test methods under Good Manufacturing Processes (GMP), and ensuring compliance with federal regulations and quality management systems. They troubleshoot instruments, mentor junior staff, ensure compliance with regulatory standards (GMP/ISO), and interpret data for project decisions.
ESSENTIAL FUNCTIONS- Develop, validate, and transfer complex analytical methods for raw materials and finished products
- Operate, maintain, and troubleshoot instrumentation, including HPLC, GC, DSC, FTIR, UV-Vis., GPC, particle size, NIR, auto-titrators, etc.
- Critically analyze data, manage investigation studies (OOS), and ensure compliance with regulatory and quality guidelines
- Execute analytical method development plans and test method documentation
- Collaborate with technical staff to conduct analyses for research projects, non-conforming products, new product introductions, nonstandard tests, etc.
- Coordinate and advise laboratory personnel in test procedures for analyzing components and physical properties of materials
- Troubleshoot analytical and physical property tests to ensure accurate results in a timely manner
- Receive off hour phone calls to assist lab supervisor and technicians with testing issues that arise which impact production schedules
- Prepare summary reports from laboratory data to ensure compliance with regulatory/quality standards and all internal/external customer requirements
- Responsible for troubleshooting, maintaining, and calibration of laboratory equipment
- Responsible for general maintenance of all laboratory equipment to include, calibrations, standard prep, and preventive maintenance
- Identify instrumentation improvements or replacement and submit justifications with budgets to management
- Coordinate and manage 3rd party service contracts as needed
- The role requires responsiveness to operational needs, which may occasionally extend beyond standard hours.
EDUCATION and Experience- Ph.D. in Analytical Chemistry with 5+ years of related experience, a Master of Science in Analytical Chemistry with 10 or more years of experience
- Experience with test method development, validation, and technical transfers is preferred.
SKILLS & ABILITIES Computer Skills MS Word and Excel
LIMS experience a plus
GENERAL LABORATORY SKILLS- Excellent laboratory skills and good mechanical aptitude.
- Broad organic chemistry knowledge base and understanding of chemical transformations.
- Expert level knowledge of chromatography and spectroscopy techniques
- Technical skills will include expertise in implementation, operation, and troubleshooting of analytical test methods and instrumentation to include gas chromatography, HPLC, GPC, pH, DSC, particle isze, UV-Vis, FT-IR, auto-titrators, etc.
Competency- Strong leadership and team building skills in an environment where initiative, collaboration, and accountability are core values.
- Use structured approaches to solve difficult, research-based problems.
- Establish and maintain positive working relationships with your team as well as internal and external customers to achieve the goals of the organization.
- Communicate effectively by speaking, listening, and writing in a clear, thorough, and timely manner using appropriate and effective communication tools and techniques.
- Make decisions by assessing situations to determine the importance, urgency, and risks, and make clear decisions that are timely and in the best interests of the organization.
- Organize by setting priorities, developing a work schedule, monitoring progress toward goals, and tracking details, data, information, and activities.
- Strong critical thinking and problem-solving skills
- Must have a customer centric approach toward internal and external customers
This job posting is not all inclusive, please see job description for details.
