Epicareer Might not Working Properly
Learn More
B

Sr Research Associate

Salary undisclosed

Apply on


Original
Simplified

Job Description

Job Description
PRIMARY RESPONSIBILITIES:
  • Conduct routine/non-routine analysis of in-process, toxicology, finished drug substance and drug product samples (i.e. release and stability testing)
  • Manage new and ongoing development projects
  • Review analytical data for compliance to SOPs (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
  • Present and participate in internal and external scientific meetings
  • Assemble and document data for quality review
  • Revise SOPs as needed (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
  • Author and execute qualification/validation protocols and write reports
  • Author scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
  • Conduct analytical investigations
  • May develop and/or optimize analytical methods
  • Applies knowledge of cGMP and GLP on a daily basis
REQUIREMENTS:
  • BS/MS degree in Chemistry or related field
  • At least 4 years (Research Associate II) or 7+ years (Sr. Research Associate) experience in an analytical development and quality control role
  • Practical knowledge of HPLC, MS, and GC
  • Knowledge and previous applications of cGMPs preferable
  • Experience following SOPs (i.e. Analytical Methods, Equipment Procedures, Material Specifications)
  • Ability to be the technical leader of a scientific project
  • Ability to interpret experimental results and correctly identify a path forward independently
  • Strong organizational skills
  • Experience recording data in laboratory notebooks or data collection forms
  • Comfortable with the operation and troubleshooting of instrumentation (lab equipment)
  • Communicate effectively, both verbally and in written form, to all levels of the organization
  • Ability to carry through on assignments, meet deadlines and time schedules
  • Ability to be flexible with workload and job duties to support team objectives
  • Experience managing development projects
  • Will build positive teamwork, encourage solutions, and solicit feedback to problems and demonstrate respectful behavior to others
  • Be an active listener; provide open, constructive feedback to suggestions or opinions presented
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job