Senior Scientist, Analytical Chemistry
The Senior Scientist, Analytical Chemistry is responsible for establishing methods to support robust characterization, specification, testing and Quality Control of raw materials, work-in-process and finished goods and for support of R&D activity. They will be designing and conducting complex experiments, as well as independently making detailed observations, analyzing data and interpreting results.
Essential Duties and Responsibilities
- Develop analytical and functional methods for testing of raw materials, intermediates and finished goods in support of ongoing Operations, Product Development and troubleshooting efforts.
- Lead test method validation efforts in accordance with company standard operating procedures, cGMPs, FDA, and ICH guidelines. Maintain methods and equipment in their validated state.
- Manage, develop, qualify troubleshoot and routinely perform analytical techniques associated with small molecules, nucleic acids, proteins, standard molecular biology reagents, and complex molecular diagnostics.
- Manage, develop, qualify, troubleshoot and routinely perform functional methods used to assess product performance and stability.
- Establish analytical and functional QC processes consistent with cGMP/GLP.
- Contribute to investigations associated with experimental results, process improvements, manufacturing failures and fields complaints.
- Evaluate new materials or materials improvements within the contact above.
- Design research plans and experiments to achieve technical project specifications.
- Contribute technical knowledge to improve laboratory capabilities in research and development efforts.
- Provide effective design, completion and analysis of complex experiments.
- Scientific trouble shooting and hands-on problem solving.
- Handle human and animal blood and body fluids with confidence.
- Simultaneous management of ongoing experiments.
- Analyze and interpret complex data and solve complex problems through thoughtful decision making process.
- Present clear project summaries in written and verbal formats to internal and external scientific and management teams.
- Work with other departments for transfer of projects or knowledge.
- Adhere to applicable regulatory guidelines.
- Assists in hiring and directing the work of the Research Associates.
- Any soft skills which are required to perform the job e.g. excellent communication, teamwork, etc.
- Ability to apply basic statistical knowledge.
- Ability to meet project goals and execute experiments.
- Ability to apply strong organization and time management skills.
- Ability to write detailed technical documents and standard operation procedures.
- Ability to apply excellent interpersonal skills in a team environment.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work designated schedule.
- Ability to work nights and/or weekends.
- Ability to lift up to 10 pounds for approximately 10% of a typical working day.
- Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
- Ability to work in front of a computer screen and/or perform typing for approximately 50% of a typical working day.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to travel approximately 0-10% of working time.
- Ability to travel 10% of working time away from work location, may include overnight/weekend travel.
- Ph.D in analytical chemistry, molecular biology, biochemistry or related field; OR Master's analytical chemistry, molecular biology, biochemistry or related field and 2+ years of laboratory experience in lieu of Ph.D.
- 8+ years of laboratory experience.
- 5+ years of industry experience.
- Demonstrated skills in reverse phase and ion exchange HPLC/UPLC with small molecules and biomolecules such as nucleic acids, oligonucleotides or proteins.
- Good understanding and demonstrate skills in modern analytical techniques such as UV/VIS spectrophotometers, FTIR, mass spectrometry, NMR, and capillary electrophoresis, and their applications.
- Knowledge of common laboratory techniques such as in PCR, qPCR, and ELISA.
- Demonstrated expertise in test methods validation.
- Familiarity with DNA, RNA and protein-based techniques.
- Experience working with outside service laboratories.
- Basic computer skills to include Internet navigation, Email usage, and word processing.
- Proficient in Microsoft Office to include Excel macros and pivot tables and Word mail merge.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Experience with diagnostic assay development and FDA regulated products.
- Previous experience working with biological fluids such as blood, saliva, urine.