Job Description
Job Type
Full-time
Description
The Analytical Chemist plays a fundamental role in Sterilex R&D by enabling New Product Development and Product Stewardship initiatives. This role is responsible for developing and validating new analytical methods to support new product development and manufacturing quality control processes. The ideal candidate has experience with basic wet chemistry quality control methods, analytical chemistry instrumentation, method development, statistics, and validation of those methods under Good Laboratory Practices. The candidate works closely with R&D Formulation Chemists and key contacts in Operations. This position is regularly scheduled to be staffed Monday through Friday, 8:30 a.m. to 5:00 p.m. with occasional overtime as needed to support department and company business needs.
KEY RESPONSIBILITIES 1. Analytical Chemistry Method Development & Validation - Improve existing analytical methods and develop new methods to support new product development and product stewardship initiatives.
- Validate and maintain the portfolio of current analytical methods utilized in Sterilex chemistry labs.
2. R&D Product Stewardship & Technical Support
- Lead initiatives to support existing products, such as qualification of new and equivalent raw materials or locally sourced raw materials in new geographies.
- Identify key raw material characteristics, contaminants, unreacted byproducts, etc. using sound analytical techniques.
- Conduct and/or oversee GLP chemical characterization studies of current or in-development products
- Serve as GLP study director or sponsor as needed in studies supporting regulatory approval.
- Respond to field / customer technical support inquiries as needed.
3. Quality Control Method Transfer & Support
- Lead or co-lead the qualification of manufacturing QC procedures, specifications and processes.
- Provide on-going support of manufacturing QC methods & quality control troubleshooting, working jointly with Sterilex Operations.
- Identify cost effective and relatively simple analytical methods for co-packers, especially for critical chemical components in raw materials and finished goods.
4. Analytical Chemistry Laboratory Quality Management & Operations
- Work jointly with QA to maintain the analytical chemistry lab quality program in full compliance with Sterilex QMS practices
- Develop, implement, and maintain laboratory safety protocols, ensuring compliance with all laboratory safety rules and regulations.
- Oversee regular maintenance as well as scheduling and execution of annual preventative maintenance/calibrations of Sterilex analytical instruments within chemistry and analytical labs
- Identify analytical equipment gaps for the Sterilex laboratory with the ability to propose cost effective equipment solutions.
- Identify and cooperatively manage third-party analytical lab relationships when outsourcing is required.
5. Uphold R&D Process Rigor & Foster Talent Development
- Conduct and oversee essential training of new technician hires
- Use experience to propose improvements to R&D processes and contribute innovative ideas for product improvements and new product concepts.
- Prepare and present written and oral reports on research findings, project status, literature reviews, and technical issues that affect the business.
- Survey scientific literature to remain current with developments and stay abreast of current trends, practices, regulatory changes that would impact Sterilex products.
- Interface effectively with Sterilex scientific, business development, and management staff to understand Sterilex markets, innovation and product development goals.
- Document and protect intellectual property by maintaining laboratory notebooks and timely completion of other patent-related documentation.
- Adhere to Sterilex's Stage Gate and Quality Management processes, use of associated tools, and documentation of research, project status, recommendations, and decisions made.
Requirements
QUALIFICATIONS •
Education: B.S. or M.S. degree in Chemistry or related degree from an accredited college or university. Ideally a degree is in Analytical Chemistry and/or with an emphasis on Analytical Chemistry.
•
Experience: - 5+ years of independent research or development experience in an academic or industrial analytical chemistry or QC laboratory setting
- Moderate+ experience with chromatographic (HPLC, GC) and spectroscopic (MS, UV/Vis) analytical techniques and basic wet chemistry methods (titrations, pH, surface tension measurements, foam tests, etc.)
- In-depth working knowledge of analytical method development, method transfer, and method validation. Experience working in a Good Laboratory Program (GLP) environment and validation of methods under GLPs.
• Skills:
- Ability to draw scientifically supportable conclusions and recommendations, and develop follow-up experiments as appropriate.
- Demonstratable organizational skills and ability to maintain a clean and orderly working environment
- Demonstrate ability to understand chemical interactions and reactions and propose analytical methods to confirm.
- Utilize industry standard statistical software and methods when reporting results.
- Ability to execute written procedures and experiments with minimal supervision.
• Key Competencies:
- Ability to recognize inconsistencies in data and execute corrective actions in consultation with R&D management to mitigate issues
- Understanding of industrial laboratory processes and procedures including proper maintenance of laboratory notebooks and general laboratory safety procedures
- Ability to read, comprehend and follow documents, including standard operating procedures, test methods, safety rules and regulations, and instrument operating and maintenance instructions.
- Motivated to take full ownership of assigned tasks
- Competent to prepare and carefully review figures, computations, tests, reports, etc., and ensure internal consistency.
- Good written and oral communication skills and effective interpersonal skills
- Computer literate: MS Office, statistical software, programs to operate equipment, other related software, email etc.
- Ability to work independently, multi-task and balance priorities
Job Tags
Full time, Monday to Friday,