Research Scientist, Biopharma (Core Shift)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Join Us as a Research Scientist within our Biopharma team – 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 a Research Scientist, you will conduct and provide technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR perform troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. You will design and execute method development/validation and/or extractable/leachable studies independently and interpret and review analytical data for self and others OR design and execute multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) Knowledge of general chemistry, biochemistry techniques (SDS-PAGE, Western Blot, total protein by BCA or micro BCA assay, ELISA)), methods and procedures. You will routinely act as the technical project leader for multiple projects, provide updates, review and evaluate data, write reports and protocols. What You'll Do: •Independently performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds or equivalent levels of expertise and experience in mass spectrometetry or other related areas such as structural elucidation or extractable leachable testing in a variety of formulations and/or delivery systems. Designs and executes experiments independently for self and others. •Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. •Leads analytical (procedural and instrumental) troubleshooting sessions. •Assists business development group in technical sales and marketing, and presents posters at technical conferences. •Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities. •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: •Bachelor's degree or equivalent and relevant formal academic / vocational qualification •Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). 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, Abilities: •Intermediate knowledge of general chemistry and separation science •Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance •Full knowledge of technical operating systems •Ability to independently optimize analytical methods •Ability to independently perform root cause analysis for method investigations •Proven technical writing skills •Proven problem solving and troubleshooting abilities •Effective written and oral communication skills as well as presentation skills •Time management and project management skills •Ability to mentor others on technical operating systems •Ability to independently review and understand project proposals/plans •Ability to work in a collaborative work environment with a team 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.