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Senior Scientist - Automation Specialist

Pharmaceutical Product Development (PPD)

Richmond, Virginia, United States of America

Job Description

At Thermo Fisher Scientific, you’ll discovermeaningful work that makes a positive impact on a globalscale. Join our colleagues in bringing our Mission to life - enabling our customers tomaketheworldhealthier,cleanerandsafer. We provide ourteams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Yourdeterminationto deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:
Performs sophisticated laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates andanalyzesdata and records data in adherence with PPD SOP's and the industry. Routinely acts 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.

Key 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 executes experiments with minimaldirection.
  • 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 clientneeds 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 crafting method validation or method transfer protocols and establish project timelines.
  • Reviews, interprets, andanalyzesdata for technical, quality and compliance to protocols, methods, SOPs, client criteria and GoodManufacturingPractices (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.

Keys to Success
Education and Experience:
Bachelor's degree orequivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Knowledge, Skills and Abilities:
  • Solidunderstanding and knowledge of general chemistry and separation science
  • Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA mentorship
  • Ability to utilize Microsoft Excel and Word to perform tasks
  • Proficiency on technical operating systems
  • Provenproblemsolvingandtroubleshootingabilities
  • Effective oral and written communication skills
  • Proventrackrecord in technical writing skills
  • Time management and project management skills
  • Ability to work in a collaborative work environment with a team
  • Provenproblemsolvingandtroubleshootingabilities
  • Ability to train junior staff

Benefits
We offer competitiveremuneration,annualincentiveplanbonus, healthcare, and a range of employee benefits. ThermoFisherScientificoffers employment with an innovative,forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity,intensity,involvement, and innovation!

Job posted: 2024-05-22

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