Associate Research Scientist performing analytical testing and method optimization for biopharma products. Leading project teams and ensuring compliance with quality standards.
Responsibilities
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
Job title
Associate Research Scientist – Technical Lead, Biopharma
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