
Associate Research Scientist – Technical Lead, Biopharma
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Office
Location: Athlone • Ireland
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Job Level
About the role
- Independently performs analytical testing, method optimization/validation, and/or other specialist technologies studies OR method transfers for 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 completes experiments independently
- Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents
- Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents
- Communicates data and technical issues to clients on a weekly basis (or as needed)
- Provides technical mentorship and training to staff
- Leads analytical (procedural and instrumental) troubleshooting sessions
- Assists in preparation and implementation of SOPs and quality systems
- Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP)
- Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
Requirements
- Degree or equivalent in Chemistry or Biochemistry
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- 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
Benefits
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Accessibility service for job seekers requiring accommodations
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical testingmethod optimizationmethod validationSDS-PAGEWestern BlotBCA assayELISAmethod developmentroot cause analysistechnical writing
Soft skills
problem solvingtroubleshootingtime managementproject managementwritten communicationoral communicationcollaborationmentorshipindependencecritique