Study Lead, Biopharma

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Join Us as an Associate Research Scientist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As an Associate Research Scientist, you will perform complex laboratory analysis of pharmaceutical products and proficiently use analytical instrumentation, calculate and analyze data and record data in adherence with PPD SOP's and the industry. You will routinely act as the project leader on multiple projects, interact with clients, review and evaluate data, write reports and protocols. You will be responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members. What You'll Do: •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. Education and Experience Requirements: •Degree or equivalent in Chemistry or Biochemistry 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. •Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Knowledge, Skills, Abilities •Knowledge of general chemistry, biochemistry techniques (SDS-PAGE, Western Blot, total protein by BCA or micro BCA assay, ELISA) •Proven experience of method development of identity and purity assays •Ideally experience in leading CMC studies for biopharmaceutical products including method validation •Proficiency on technical operating systems (including Image Lab software) •Proven problem solving and troubleshooting abilities •Ability to independently perform root cause analysis for method investigations •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 Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.