Sr. Analytical Research Scientist
The Senior Senior Research Scientist position will support R&D by supporting various activities (independently, but with limited supervision) within the analytical development group including test method development, method qualification/validation, testing of various samples in support of formulation development, performing data analysis and review and preparation of reports and other technical documents. This position will work closely with Formulation Development team members. The successful candidate will perform job functions in accordance with the OSHA guidelines and ensure full compliance with FDA regulations and standard operating procedures.
location: Bridgewater, New Jersey
job type: Contract
salary: $40 - 45 per hour
work hours: 9 to 5
- Under limited supervision, developing and optimizing fit-for-purpose analytical methodologies across early through late stage product development for injectable and ophthalmic drug products.
- Under limited supervision, designing and executing appropriate pre-validation and/or validation studies required to support analytical methodologies.
- Testing various samples in support of formulation development, subsequently followed by interpretation of results to provide meaningful guidance to the team.
- Verifies co-workers' calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data.
- Evaluates compendial and other published methods, supports new method development activities. Interprets and tabulates results of analysis.
- Records the results in approved notebooks, reports and logbooks.
- Helps maintain inventory of glassware, chemicals and materials needed for chemical analysis.
- Required to maintain and clean laboratory instruments and equipment.
- Required to design and/or execute departmental methods, protocols and SOPs.
- Required to assist in writing, reviewing, or revising procedures.
- Perform other laboratory related miscellaneous duties as required.
- A Ph.D. degree in Analytical Chemistry or related field, with 2+ years of experience, or an M.S. with 3+ years of experience, or a Bachelor's degree with 5+ years of experience, or equivalent combination of education and experience is required.
- 3 years minimum experience supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeias (USP, EP) are preferred.
skills: HPLC, Analytical Chemistry, Laboratory Information Management Systems (LIMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.