Scientist I – CMC/Gmp
| Company | BioAgilytix |
|---|---|
| Location | Durham, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Mid Level, Senior |
Requirements
- Bachelor’s degree in chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than six (6) years’ experience in a scientific laboratory environment; or
- Master’s degree in chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than four (4) years’ experience in a scientific laboratory environment; or
- PhD in chemistry, pharmaceutical science, molecular biology, biochemistry, immunology, biotechnology, or related field with not less than 2 years’ experience in a scientific laboratory environment
- Ability to develop analytical assays in some or all of the following platforms: HPLC, UPLC, CE, iCIEF, UV-Vis, SDS-PAGE, Western Blot, ELISA, USP Compendials and similar
- Must work effectively within team to meet objectives under time constraints
- Ability to take direction well and multi-task
- Detail oriented and highly organized
- Ability to access and use a variety of computer software
- Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
- Frequently interacts with others to obtain or relate information to diverse groups
- Requires multiple periods of intense concentration
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
- Ability to perform under stress and multi-task
- Excellent oral and written communication skills
- Proficient in the use of MS Excel and Word
- Demonstrated experience serving in a supervisor role and leading teams
- Knowledge and application of regulatory guidance to experimental planning and design
- Experience working in GxP environments and demonstrated knowledge of GxP regulations
Responsibilities
- Serve as lead scientist on assay development projects
- Serve as lead scientist on validation
- Present data to clients
- Independently write plans and reports for validation
- Responsible for prompt identification and notification of deviations
- Perform assays according to GMP guidelines
- Follow GMP guidelines for validation of assays
- Develop and run assays independently
- Prepare worksheets independently
- Analyze and interpret data
- Prepare summary tables
- Peer review raw data
- Troubleshoot assays
- Write SOPs
- Write plans/reports for sample analysis
- Order and keep accurate inventories of supplies for laboratory needs and forecast future needs based on projected project needs
- May serve as principal investigator on a project
- May prepare and submit deviations
- Manage project timelines/scheduling
- Manage budget and revenue for projects
- Communicate with client
- Train analysts/junior scientists
- Ability to assist with definition of project scope and proposal preparation (SME)
- Prepare and review scientific training materials
- Set up studies in LIMS system
- Other duties as needed
Preferred Qualifications
-
No preferred qualifications provided.