The Scientist Level III is a seasoned AD chemist that performs development, optimization, transfer and validation of analytical methods for products and raw materials. When required, the scientist supports testing of raw materials, in-process, finished product and stability samples in support of clinical studies, stability and product development. Tests include assay, chromatographic purity, content uniformity, particle size distribution, density, water determination by KF and TOC according to in-house methods and USP monographs.
Specific Job Responsibilities
- Performs development, optimization, transfer and validation of methods for products and raw materials.
- Troubleshoots methods to determine root causes of issues and verifies methods for release to the lab.
- Prepares analytical methods, protocols, reports and standard operating procedures, as required.
- Performs testing of raw materials, in-process, finished product and stability samples including HPLC assay, chromatographic purity, content uniformity, particle size distribution, density, water determination by KF and TOC according to in-house methods and USP monographs in support of clinical studies and biopharma drug product development.
- Maintains accurate lab notebooks, completes all related analytical reports, writes summaries and keeps proper documentation in compliance with SOP’s. Ensures notebooks are reviewed in a timely manner in accordance with SOP requirements.
- Assists in maintaining and calibrating laboratory equipment (e.g. HPLC, GC).
- Maintains the laboratory and work areas as per good housekeeping practices and in compliance with EHS.
Required Skills and Competencies
- Prior experience with the optimization and validation of analytical test methods.
- Working knowledge of laboratory instrumentation as referred to in job responsibilities and associated software where applicable. Extensive experience with Empower is required.
- Ability to work on multiple method (HPLC, GC, PSD) projects of a complex nature simultaneously.
- Experience investigating complex test failures and determining root causes.
- Ability to carry out and complete necessary computations and present / interpret data.
- Working knowledge of USP, ICH and FDA guidelines in a GMP regulated lab environment.
- Possesses and demonstrates a wide degree of creativity and problem-solving skills.
- Excellent communications skills with demonstrated ability to communicate clearly in English in both written and spoken form.
Education and Experience
- BS degree in chemistry or related discipline. MS degree preferred.
- 5 plus years relevant experience with BS degree. 3 plus years with MS. Pharmaceutical lab experience required, with biopharma lab experience preferred.
- Able to perform laboratory function associated with position and required in a research lab.
- Standing to perform bench tests, bending, lifting up to 40 lbs, and ability to wear all required safety equipment such as safety glasses, mask, gloves, lab coat as work and environment require.