Onsite Associate Research Scientist – Technical Lead, Biopharma

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About the role

  • 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

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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