Thermo Fisher Scientific · 1 day ago
Associate Research Scientist - CSD - LCMS
Thermo Fisher Scientific is a leading company in the field of scientific research and development. They are seeking an Associate Research Scientist to perform complex sample preparation and analysis procedures, manage laboratory activities, and provide mentorship to junior scientists.
Research
Responsibilities
Independently performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices
Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications
Coordinates laboratory activities of other team members in conjunction with the lab management
Performs study design and protocol authoring
Leads data evaluation and study close-out
Provides technical guidance and mentorship to junior scientists
Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines
Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs
Leads troubleshooting for various equipment & instruments
Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria
Navigates the OOS/OOT/Atypical investigation process
Leads more complex investigations and Root Cause Analysis and leads CAPAs
Independently manages QC responsibilities
Communicates project status to project leader and helps to address gaps and solutions to overcoming roadblocks in project team workflow
May act as project leader
Independently completes QA facing tasks
Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross departmental input and/or collation of data etc.)
Mentors other staff members in applicable areas as needed
Qualification
Required
Must be legally authorized to work in the United States without sponsorship
External candidates must be able to pass a comprehensive background check, which includes a drug screening
BS and six years of experience OR MS and four years of experience OR PhD and two years of experience
Knowledge of relevant scientific principles applicable to role, ideally seeking candidates with LCMS and PI experience
Ability to independently perform root cause analysis for quality records
Proficiency on technical operating systems
Proven problem solving and troubleshooting abilities
Proven ability in technical writing skills
Time management and project management skills
Good written and oral communication skills
Ability to work in a collaborative work environment with a team
Ability to train junior staff
Ability to mentor others on technical operating systems
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and regulatory guidance
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.