Sr Scientist - Chromatography Science - Research and Development

Thermo Fisher Scientific•Richmond, VA

1d•Onsite

About The Position

As a Sr Scientist you will perform complex laboratory analysis of pharmaceutical products and proficiently use analytical instrumentation. Routinely act as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.

Requirements

Bachelor's degree (life sciences preferred) or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or a Master's degree and three years of experience or a PhD.
Solid understanding and knowledge of general chemistry and separation science, High Performance Liquid Chromatography (HPLC) and Mass Spectrometry
Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
Ability to apply Microsoft Excel and Word to perform tasks
Proficiency on technical operating systems
Proven problem solving and troubleshooting abilities
Effective oral and written communication skills
Proven ability in technical writing skills
Time management and project management skills
Ability to work in a collaborative work environment with a team
Proven problem solving and troubleshooting abilities
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Responsibilities

Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems.
Understands and conforms to methods and protocols applicable to assigned tasks.
Designs and drives experiments with minimal supervision.
Prepares study protocols, project status reports, final study reports and other project-related technical documents.
Communicates data and technical issues to the client and responds to client needs and questions.
Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.
Assists with quality systems and new equipment.
Assists in designing method validation or method transfer protocols and establish project timelines.
Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.