Discover Impactful Work:

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. A Day in the

Life:

Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines. Independently performs and gives guidance on 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 for stability and analytical testing. 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. Reviews overall study results. 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. Coordinates laboratory activities of other team members in conjunction with lab management. Performs study design & protocol authoring. Leads data evaluation and study close-out. 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. Keys to

Success:

BS and six years of experience OR MS and four years of experience OR PhD and two years of experience In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Knowledge, Skills and Abilities:

Knowledge of relevant scientific principles applicable to role 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

Working Conditions and Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 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Associate Research Scientist - Principal Investigator - LCMS